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Cows' milk protein allergy in children - NICE CKS

http://cks.nice.org.uk/cows-milk-protein-allergy-in-children#!diagnosissub

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Cows' milk protein allergy in children


Last revised in June 2015

Changes

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Last revised in June 2015


June 2015 minor updates:
The sections on hypoallergenic formulas have been updated, information on Amino acid feeds has been amended, and details of a referenced document have
been amended.
Links to useful fact sheets and tools have been added to relevant sections of the topic.
The section on manging children whose symptoms do not improve despite strict adherence to an strict elimination diet has been amended to reflect the fact that
these children may have multiple food allergies (for example an allergy to cows' milk and soya), and other foods may also need to be eliminated.
September to December 2014 this is a new CKS topic. The evidence base has been reviewed in detail, and recommendations are clearly justified and
transparently linked to the supporting evidence.

Previous changes

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There are no previous changes.

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Cows' milk protein allergy in children - NICE CKS

http://cks.nice.org.uk/cows-milk-protein-allergy-in-children#!diagnosissub

Update

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New evidence

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Evidence-based guidelines
No new evidence-based guidelines since 1 October 2014.
HTAs (Health Technology Assessments)
No new HTAs since 1 October 2014.
Economic appraisals
No new economic appraisals relevant to England since 1 October 2014.
Systematic reviews and meta-analyses
No new systematic reviews or meta-analyses since 1 October 2014.
Primary evidence
No new randomized controlled trials published in the major journals since 1 October 2014.

New policies

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No new national policies or guidelines since 1 October 2014.

New safety alerts

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No new safety alerts since 1 October 2014.

Changes in product availability

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No changes in product availability since 1 October 2014.


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Cows' milk protein allergy in children - NICE CKS

http://cks.nice.org.uk/cows-milk-protein-allergy-in-children#!diagnosissub

Goals
To support primary healthcare professionals to:
Recognize the possible features of cows' milk protein allergy in children
Assess a child with suspected cows' milk protein allergy
Diagnose and manage cows' milk protein allergy in primary care, if appropriate
Refer a child with suspected cows' milk protein allergy, when appropriate, to secondary or specialist care for diagnosis and management

Definition

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What is it?
Cows' milk protein allergy is an immune-mediated allergic response to proteins in milk [Vandenplas et al, 2007 (/cows-milk-protein-allergyin-children#!references/-617807); Ludman et al, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807)].
Milk contains casein and whey fractions, each of which have five protein components.
A person can be sensitized to one or more components within either group.
Cows' milk protein allergy is classified according to the underlying cause [Vandenplas et al, 2007 (/cows-milk-protein-allergy-in-children#!references
/-617807); Caffarelli et al, 2010 (/cows-milk-protein-allergy-in-children#!references/-617807);NICE, 2011 (/cows-milk-protein-allergyin-children#!references/-617807); Koletzko et al, 2012 (/cows-milk-protein-allergy-in-children#!references/-617807); Ludman et al, 2013 (/cowsmilk-protein-allergy-in-children#!references/-617807)]:
Immunoglobulin E (IgE)-mediated reactions are acute and frequently have a rapid onset. They occur up to 2 hours after ingestion of cows' milk, usually within
2030 minutes.
Non-IgE-mediated reactions are generally delayed and non-acute. They manifest up to 48 hours or even 1 week after ingestion of cows' milk protein [Koletzko
et al, 2012 (/cows-milk-protein-allergy-in-children#!references/-617807)].
Mixed IgE and non-IgE allergic reactions involve a mixture of both IgE and non-IgE responses.
Food allergy should not be confused with food intolerance, which is a non-immunological reaction that can be caused by enzyme deficiencies,
pharmacological agents, and naturally occurring substances [NICE, 2011 (/cows-milk-protein-allergy-in-children#!references/-617807)].

Causes

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What causes it?


Cows' milk protein allergy is an abnormal response of the immune system to usually harmless proteins found in cows' milk. The immune system releases a
number of chemicals which then trigger an allergic reaction.
Immunoglobulin E (IgE)-mediated cows' milk protein allergy is caused by the release of histamine and other mediators from the mast cells and basophils in
response to cows' milk protein.
Non-IgE-mediated cows' milk protein allergy is thought to be caused by T-cells.

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Cows' milk protein allergy in children - NICE CKS

http://cks.nice.org.uk/cows-milk-protein-allergy-in-children#!diagnosissub

[Motola, 2004 (/cows-milk-protein-allergy-in-children#!references/-617807); Anand, 2014 (/cows-milk-protein-allergy-in-children#!references/-617807)]

Prevalence

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How common is it?


Cows' milk protein allergy is one of the most common childhood food allergies in the developed world, second to egg allergy [Koletzko et al, 2012 (/cowsmilk-protein-allergy-in-children#!references/-617807); Ludman et al, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807)].
It affects about 7% of formula or mixed-fed (breast and formula-fed) infants, with the highest prevalence during the first year of life [Caffarelli et al, 2010 (/cowsmilk-protein-allergy-in-children#!references/-617807)].
Exclusively breastfed babies can also develop cows' milk protein allergy due to protein in the maternal diet transferring through breast milk. However, the
incidence is much lower than for formula or mixed-fed infants.
Only about 0.5% of exclusively breastfed infants show reproducible clinical reactions to cows' milk protein, and these are mostly mild to moderate in intensity
[Vandenplas et al, 2007 (/cows-milk-protein-allergy-in-children#!references/-617807)].

Risk factors

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What are the risk factors?


It is difficult to predict which children will develop a food allergy. However, the following risk factors are associated with an increased risk of cows'
milk protein allergy [Vandenplas et al, 2007 (/cows-milk-protein-allergy-in-children#!references/-617807); NICE, 2011 (/cows-milk-protein-allergyin-children#!references/-617807); Ludman et al, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807)]:
Associated atopic comorbidities (such as asthma and eczema)
The frequency of severe reactions is higher in children with asthma, especially those with poorly controlled asthma, than in children without asthma.
Family history of atopy
Family history of atopy is a risk factor for developing food allergies, although only an allergic predisposition is inherited, not specific allergies.
Some experts suggest that babies who are exclusively breastfed during the first 46 months of life are less likely to develop cows' milk protein allergy than
babies who are formula fed [Vandenplas et al, 2007 (/cows-milk-protein-allergy-in-children#!references/-617807)].

Prognosis

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What is the prognosis?


Immunoglobulin E (IgE)-mediated cows' milk protein allergy
Prospective longitudinal studies on children with IgE-mediated (/cows-milk-protein-allergy-in-children#!backgroundsub/-617748) cows' milk protein allergy
suggest that 5357% will be milk tolerant by 5 years of age [Sicherer et al, 2010 (/cows-milk-protein-allergy-in-children#!references/-617807); Elizur et al, 2012
(/cows-milk-protein-allergy-in-children#!references/-617807)].
However, there is some evidence that IgE-mediated cows' milk protein allergy is more likely to persist in children with asthma or allergic rhinitis; children who
have more severe reactions; and children with a larger reaction on skin prick test, or higher milk-specific IgE antibody levels, at diagnosis (/cows-milk-proteinallergy-in-children#!scenariorecommendation)[Saarinen et al, 2005 (/cows-milk-protein-allergy-in-children#!references/-617807); Fiocchi et al, 2010 (/cows-

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Cows' milk protein allergy in children - NICE CKS

http://cks.nice.org.uk/cows-milk-protein-allergy-in-children#!diagnosissub

milk-protein-allergy-in-children#!references/-617807); Sicherer et al, 2010 (/cows-milk-protein-allergy-in-children#!references/-617807); Elizur et al, 2012


(/cows-milk-protein-allergy-in-children#!references/-617807); Ludman et al, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807)].
Non-IgE-mediated cows' milk protein allergy
The prognosis of non-IgE-mediated (/cows-milk-protein-allergy-in-children#!backgroundsub/-617748) cows' milk protein allergy is less known [Ludman et al,
2013 (/cows-milk-protein-allergy-in-children#!references/-617807)].
However, studies have shown that most children with non-IgE-mediated cows' milk protein allergy will be milk tolerant by 3 years of age [Sicherer et al, 1998
(/cows-milk-protein-allergy-in-children#!references/-617807); Saarinen et al, 2005 (/cows-milk-protein-allergy-in-children#!references/-617807); Venter et al,
2013 (/cows-milk-protein-allergy-in-children#!references/-617807)].
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Complications
What are the complications?

Cows' milk protein allergy may result in poor nutritional intake or malabsorption, leading to possible:
Chronic iron deficiency anaemia.
Faltering growth, with the associated consequences in a growing child.
Rare cases of anaphylactic shock leading to death have been reported following cows' milk protein ingestion in sensitized children.
Heiner's syndrome, a milk-induced pulmonary disease, is a rare complication of cows' milk protein allergy in children. Severe cases may be complicated with
pulmonary haemosiderosis, which should be suspected in the presence of anaemia or haemoptysis [Moissidis et al, 2005 (/cows-milk-protein-allergyin-children#!references/-617807)].
[Koletzko et al, 2012 (/cows-milk-protein-allergy-in-children#!references/-617807)]
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When to suspect
When should I suspect cows' milk protein allergy in a child or young person?
Suspect cows' milk protein allergy in children:

Who have one or more of the signs and symptoms listed in Table 1 (/cows-milk-protein-allergy-in-children#!diagnosissub/-617759), paying particular attention
to children with persistent symptoms that involve different organ systems.
Whose symptoms do not respond adequately to treatment for atopic eczema, gastro-oesophageal reflux disease, and/or chronic gastrointestinal symptoms
(including chronic constipation).
If cows' milk protein allergy is suspected in a child, take an allergy-focused clinical history (/cows-milk-protein-allergy-in-children#!diagnosissub:1) tailored to
the presenting symptoms.
Table 1 . Symptoms and signs of possible food allergy.*
IgE-mediated cows' milk protein allergy

Non-IgE-mediated cows' milk protein allergy

Speed of onset of symptoms

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Acute and frequently has a rapid onset (up to 2 hours after ingestion)

http://cks.nice.org.uk/cows-milk-protein-allergy-in-children#!diagnosissub
Non-acute and generally delayed (manifest up to 48 hours or even 1 week after
ingestion)

Skin reactions
Pruritus

Pruritus

Erythema

Erythema

Acute urticaria localized or generalized

Atopic eczema

Acute angio-oedema most commonly of the lips, face, and around the
eyes
Gastrointestinal symptoms
Angioedema of the lips, tongue, and palate

Gastro-oesophageal reflux disease

Oral pruritus

Loose or frequent stools

Nausea

Blood and/or mucus in stools

Colicky abdominal pain

Abdominal pain

Vomiting

Infantile colic

Diarrhoea

Food refusal or aversion


Constipation
Perianal redness
Pallor and tiredness
Faltering growth in conjunction with at least one or more gastrointestinal symptoms
above (with or without significant atopic eczema)

Respiratory symptoms (usually in combination with one or more of the above symptoms and signs)
Lower respiratory tract symptoms (cough, chest tightness, wheezing, or
shortness of breath)

Lower respiratory tract symptoms (cough, chest tightness, wheezing, or shortness of


breath)

Upper respiratory tract symptoms (nasal itching, sneezing, rhinorrhoea, or


congestion [with or without conjunctivitis])
Other symptoms
Symptoms and signs of anaphylaxis or other systemic allergic reactions

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* Note that the list in this table is not exhaustive, and the absence of these symptoms does not exclude food allergy. IgE immunoglobulin E
Adapted from: [NICE, 2011 (/cows-milk-protein-allergy-in-children#!references/-617807)]

Basis for recommendation

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These recommendations are based on the National Institute for Health and Care Excellence (NICE) guideline Food allergy in children and young people. Diagnosis
and assessment of food allergy in children and young people in primary care and community settings[NICE, 2011 (/cows-milk-protein-allergy-in-children#!references
/-617807)].
When to suspect cows' milk protein allergy
The NICE guideline development group (GDG) considered the evidence on factors that would prompt investigation of possible food allergy in children and young
people [NICE, 2011 (/cows-milk-protein-allergy-in-children#!references/-617807)].
Although most of the studies identified were of low quality, the GDG felt that symptoms and signs should be highlighted as a first recommendation because it
would be these that the parents or carers would present to their GP.
Based on their expertise and clinical experience, the NICE GDG agreed that [NICE, 2011 (/cows-milk-protein-allergy-in-children#!references/-617807)]:
The initial assessment of symptoms and signs should be split according to whether an immunoglobulin E (IgE) or non-IgE-mediated food allergy is most
likely, and that particular attention should be given to persistent symptoms that affect different organ systems.
If symptoms do not respond adequately to treatment for atopic eczema, gastro-oesophageal reflux disease, and/or chronic gastrointestinal symptoms, cows'
milk protein allergy should be suspected.
Symptoms and signs of cows' milk protein allergy
The NICE GDG consensus was used to list the most common symptoms of food allergy, based on their expertise and clinical experience [NICE, 2011 (/cowsmilk-protein-allergy-in-children#!references/-617807)].

Assessment

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How should I assess a child or young person with suspected cows' milk protein allergy?
If cows' milk protein allergy is suspected, take an allergy-focused clinical history tailored to the presenting symptoms (/cows-milk-protein-allergyin-children#!diagnosissub) and the age of the child.
Ask about:
Any history of atopic disease (asthma, eczema, or allergic rhinitis) or food allergy.
Any family history of atopic disease or food allergy in parents or siblings.

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Details of any foods that are avoided and the reasons why.
Cultural and religious factors that affect the foods they eat.
Who has raised the concern about the suspected food allergy, and what the suspected allergen is.
The childs feeding history, including the age at which they were weaned and whether they were breastfed or formula fed. If the child is currently being
breastfed, ask about the mothers diet.
Details of any previous treatment, including medication such as antihistamines, for the presenting symptoms and the response to this.
Any response to the elimination and reintroduction of foods.
Assess the presenting symptoms and other symptoms that may be associated with food allergy. Ask about:
The age of the child when symptoms first started.
Speed of onset of symptoms following food contact, duration of symptoms, severity of reaction, and frequency of occurrence.
Setting of reaction (for example at school or home).
Reproducibility of symptoms on repeated exposure.
What food, and how much exposure to it, causes a reaction.
The European Academy of Allergy and Clinical Immunology (EAACI) has published an extensive Allergy-Focussed Diet History tool (http://www.ctajournal.com
/content/supplementary/s13601-015-0050-2-s1.pdf) for healthcare professionals.
Based on the findings of the allergy-focused clinical history, physically examine the child, paying particular attention to:
Growth and physical signs of malnutrition.
Signs indicating other comorbidities (such as atopic eczema, asthma, or allergic rhinitis).
Signs indicating an alternative diagnosis (/cows-milk-protein-allergy-in-children#!diagnosissub:2).
Following the allergy-focused clinical history:
If immunoglobulin E (IgE)-mediated cows' milk protein allergy is suspected, see the section on Managing suspected IgE-mediated allergy (/cowsmilk-protein-allergy-in-children#!scenariorecommendation) for information on confirming the diagnosis.
If non-IgE-mediated cows' milk protein allergy is suspected, see the section on Managing suspected non-IgE-mediated allergy (/cows-milk-protein-allergyin-children#!scenariorecommendation:1) for information on confirming the diagnosis.

Basis for recommendation

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These recommendations are largely based on the National Institute for Health and Care Excellence guideline Food allergy in children and young people. Diagnosis
and assessment of food allergy in children and young people in primary care and community settings[NICE, 2011 (/cows-milk-protein-allergy-in-children#!references
/-617807)].
Taking an allergy-focused clinical history
The NICE guideline development group (GDG) considered the evidence on factors that would prompt investigation of possible food allergy in children and young
people [NICE, 2011 (/cows-milk-protein-allergy-in-children#!references/-617807)].
Although most of the studies identified were of low quality, the GDG felt that signs and symptoms should be highlighted as a first recommendation because it
would be these that the parents or carers would present to their GP.
The evidence for an allergy-focused clinical history was limited; however, the GDG felt that an allergy-focused clinical history tailored to the presenting

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symptoms and age of the child should be highlighted as the next recommendation as it would reduce the chances of misdiagnosis.
In addition, a review article on the management of cows' milk protein allergy in children, identified by CKS, states that an accurate diagnosis is important in
order to avoid 'not only the risk of rickets, decreased bone mineralization, anaemia, poor growth, and hypoalbuminaemia, but also that of immediate clinical
reactions or severe chronic gastroenteropathy leading to malabsorption' [Caffarelli et al, 2010 (/cows-milk-protein-allergy-in-children#!references/-617807)].
Performing a physical examination
The NICE GDG felt that a physical examination should always follow on from an allergy-focused clinical history. Although allergies do not always affect growth,
there was a consensus that growth and nutrition were important aspects that should be highlighted.
The NICE GDG also felt it was important to assess comorbidities that may be related to food allergy [NICE, 2011 (/cows-milk-protein-allergyin-children#!references/-617807)], and expert opinion in a consensus guideline on the diagnosis and management of cow's milk protein allergy in infants
[Vandenplas et al, 2007 (/cows-milk-protein-allergy-in-children#!references/-617807)] suggests that children should also be assessed for the presence of
non-allergy related comorbidities such colic and gastro-oesophageal reflux disease (GORD). According to the authors of the consensus guideline:
In about 10% of colicky formula-fed babies, colic episodes are a manifestation of cows' milk protein allergy.
About 1520% of children with suspected or proven GORD or cows' milk protein allergy suffer from both conditions, and 1624% of children with a history of
GORD have features of cows' milk protein allergy.
The recommendation to examine the child for signs indicating an alternative diagnosis is pragmatic, based on what CKS considers to be good clinical practice.
Since the features of cows' milk protein allergy are similar to features of several other conditions, a differential diagnosis should be considered based on the
findings of the allergy-focused clinical history.
Expert opinion in a consensus guideline on the diagnosis and management of cows' milk protein allergy in infants [Vandenplas et al, 2007 (/cows-milk-proteinallergy-in-children#!references/-617807)] suggests that the patterns and timing of the signs and symptoms should aid identification of an alternative diagnosis.

Differential diagnosis

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What else might it be?


Differential diagnoses of cows' milk protein allergy include:
Food intolerance, for example lactose intolerance this may present with abdominal pain and diarrhoea following ingestion of foods containing lactose.
Note that symptoms of lactose intolerance rarely occur before the age of 6 years, but acquired or secondary lactose intolerance can occur when the
intestine is damaged, for example following gastroenteritis.
Allergic reactions to other food allergens (such as hens' eggs, soya, and wheat) or other substances (such as animal dander, moulds, and dust).
Anatomical abnormalities, such as Meckel's diverticulum.
Chronic gastrointestinal conditions, such as:
Gastro-oesophageal reflux disease see the CKS topics on GORD in children (/gord-in-children) and Dyspepsia - proven GORD (/dyspepsiaproven-gord) for more information.
Crohn's disease see the CKS topic on Crohn's disease (/crohns-disease) for more information.
Coeliac disease see the CKS topic on Coeliac disease (/coeliac-disease) for more information.
Constipation see the CKS topic on Constipation in children (/constipation-in-children) for more information.
Gatroenteritis see the CKS topic on Gastroenteritis (/gastroenteritis) for more information.
Ulcerative colitis see the CKS topic on Ulcerative colitis (/ulcerative-colitis) for more information.

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Pancreatic insufficiency (such as in cystic fibrosis).


Infections (for example urinary tract infections) see the CKS topic on Urinary tract infection - children (/urinary-tract-infection-children) for more information.

Basis for recommendation

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The information on the differential diagnoses of cows' milk protein allergy is based on expert opinion in a consensus guideline on the diagnosis and management
of cows' milk protein allergy in infants [Vandenplas et al, 2007 (/cows-milk-protein-allergy-in-children#!references/-617807)] and a review article on managing
cows' milk allergy in children [Ludman et al, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807)].
The information on acquired or secondary lactose intolerance is based on a review article on lactose intolerance [Swagerty et al, 2002 (/cows-milk-protein-allergyin-children#!references/-617807)].

Scenario: Suspected cows' milk protein allergy

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Age from 0 months to 5 years

Managing suspected IgE-mediated allergy

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How should I manage a child with suspected IgE-mediated cows' milk protein allergy?
If immunoglobulin E (IgE)-mediated cows' milk protein allergy is suspected following an allergy focused clinical history (/cows-milk-protein-allergyin-children#!diagnosissub:1):
Refer to secondary or specialist care (according to local protocol) for a skin prick and/or specific IgE antibody blood test (previously known as a
RAST test) if there is:
Faltering growth in combination with one or more of the gastrointestinal symptoms described in Table 1 (/cows-milk-protein-allergy-in-children#!diagnosissub
/-617759) in the section on When to suspect cows' milk protein allergy (/cows-milk-protein-allergy-in-children#!diagnosissub).
One or more acute systemic reactions.
One or more severe delayed reactions.
Confirmed IgE-mediated food allergy and concurrent asthma.
Significant atopic eczema where multiple or cross-reactive food allergies are suspected by the parent or carer.
Persisting parental suspicion of food allergy (especially in children with difficult or perplexing symptoms) despite a lack of supporting history.
Clinical suspicion of multiple food allergies.
Consider referring all other children to secondary or specialist care (according to local protocol) for a skin prick and/or specific IgE antibody blood
test.
These tests may be performed in primary care if the expertise to conduct and interpret the test are available.
The decision to perform a skin prick test or a specific IgE antibody blood test in primary care should also be based on the results of the allergy-focused clinical
history and whether the test is available, suitable, safe, and acceptable to the child (or their parent or carer).
Ensure the person is provided with appropriate information on:

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IgE-mediated cows' milk protein allergy, including information on what it is and the potential risk of a severe allergic reaction.
The diagnostic process (that is, skin prick test and/or specific IgE antibody blood test).
Support groups, for example Allergy UK (http://www.allergyuk.org/milk-allergy/milk-allergy) (www.allergyuk.org) and CMPA Support
(http://cowsmilkproteinallergysupport.webs.com/) (www.cmpasupport.org.uk).

Basis for recommendation

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These recommendations are largely based on the National Institute for Health and Care Excellence (NICE) guideline Food allergy in children and young people.
Diagnosis and assessment of food allergy in children and young people in primary care and community settings[NICE, 2011 (/cows-milk-protein-allergyin-children#!references/-617807)].
Skin prick test and/or specific immunoglobulin E (IgE) antibody blood test
NICE reviewed the evidence on tools for diagnosing IgE-mediated food allergies in children and young people [NICE, 2011 (/cows-milk-protein-allergyin-children#!references/-617807)]:
Very low-quality evidence from 15 studies of 3031 children showed that the skin prick, specific IgE antibody, and atopy patch tests may be useful in the
diagnosis of IgE-mediated food allergy. The following sensitivity and specificity ranges were reported:
Sensitivity ranges: skin prick test 28% to 96%; specific IgE antibody test 23% to 100%, and atopy patch test 0% to 80%.
Specificity ranges: skin prick test 46% to 100%; specific IgE antibody test 30% to 98%, and atopy patch test 70% to 100%.
The NICE guideline development group (GDG) acknowledged that the evidence was of low quality and that the tests had a wide range of specificities and
sensitivities. However, it was decided that both the skin prick and the specific IgE antibody tests (which the evidence showed were similar in their diagnostic
performance) could be considered for diagnosing IgE-mediated food allergies in children and young people.
Although the evidence showed that the atopy patch test may be useful in the diagnosis of IgE-mediated food allergy, the NICE GDG viewed this as inappropriate
because it was felt to be less well-standardized and more variable than the other two tests.
This is in line with expert opinion in a guideline issued by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), which
states that results from atopy patch tests are subjective and difficult to interpret [Koletzko et al, 2012 (/cows-milk-protein-allergy-in-children#!references
/-617807)].
The NICE GDG emphasized that allergy tests should only be carried out after taking an allergy-focused clinical history. The GDG believed that the tests would
be useful in confirming the diagnosis only if a proper history had been taken.
Referral to secondary or specialist care
When to refer
The criteria for when referral should be arranged has been extrapolated from the NICE guideline [NICE, 2011 (/cows-milk-protein-allergyin-children#!references/-617807)]. CKS recommends referral for these groups of children, given the complexities of their presentations and their increased risk
of anaphylaxis.
When to consider referral
The NICE GDG discussed the competencies that healthcare professionals needed to choose, perform, and interpret the results of the allergy tests. They also
discussed the safety of conducting the tests in primary care, bearing in mind the risk of anaphylaxis with skin prick tests.

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Based on the GDG members expertise and clinical experience, it was agreed that the tests could be carried out in community settings where the facilities are
similar to those available for routine childhood vaccinations. However, the GDG emphasized that the tests 'should only be undertaken by healthcare
professionals with the appropriate competencies to select, perform and interpret them' and should be 'undertaken where there are facilities to deal with an
anaphylactic reaction' [NICE, 2011 (/cows-milk-protein-allergy-in-children#!references/-617807)].
Recognizing that the expertise to choose, perform, and interpret these tests may not be readily available in primary care, CKS recommends considering
referral to secondary or specialist care for confirmation of the diagnosis for all other children with suspected IgE-mediated cows' milk protein allergy.
Giving information and advice
NICE reviewed the evidence on information needs for children with food allergies [NICE, 2011 (/cows-milk-protein-allergy-in-children#!references/-617807)].
Although the evidence found was limited and did not fully address the clinical question, the NICE GDG agreed that the healthcare professional should tailor
most of the information to the specific needs and background of the child.
The GDG also thought it was important to provide information on what to do while waiting for the results of diagnostic tests and confirmation of food allergy,
because there may be a delay between when the test is carried out and when the results are received, especially for specific IgE antibody blood tests.
NICE also advises that parents and/or carers of children and young people with suspected food allergy should be provided with appropriate information on the
potential impact of the suspected allergy on other healthcare issues, including vaccination [NICE, 2011 (/cows-milk-protein-allergy-in-children#!references
/-617807)]. However, the expert reviewers of this CKS topic agree that there are currently no vaccines affected by cows' milk protein allergy.
Diagnostic tests not recommended
Serum specific IgG tests: although no specific evidence was reviewed, the NICE GDG agreed that serum specific IgG tests are not appropriate for the
diagnosis and assessment of food allergy.
Vega testing, applied kinesiology, and hair analysis: due to the lack of evidence for these tests, and the lack of well-designed studies, the NICE GDG agreed
that they are not appropriate for diagnosing food allergy.
Basophil histamine release/activation, lymphocyte stimulation, mediator release assay, endoscopic allergen provocation, facial thermography, and
gastric juice analysis: expert opinion in a guideline issued by the ESPGHAN suggests that these tests are not recommended for diagnosing food allergies in
infants and children [Koletzko et al, 2012 (/cows-milk-protein-allergy-in-children#!references/-617807)].
Atopy patch test: this test is not recommended for the reasons highlighted above (/cows-milk-protein-allergy-in-children#!scenariobasis/-617830).

Managing suspected non-IgE-mediated allergy

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How should I manage a child with suspected non-IgE-mediated cows' milk protein allergy?
If non-immunoglobulin E (IgE)-mediated cows' milk protein allergy is suspected following an allergy focused clinical history (/cows-milk-proteinallergy-in-children#!diagnosissub:1):
Consider referral to secondary or specialist care if there is:
Faltering growth in combination with one or more of the gastrointestinal symptoms described in Table 1 (/cows-milk-protein-allergyin-children#!diagnosissub/-617759) in the section on When to suspect cows' milk protein allergy (/cows-milk-protein-allergy-in-children#!diagnosissub).

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One or more acute systemic reactions.


One or more severe delayed reactions.
Significant atopic eczema where multiple or cross-reactive food allergies are suspected by the parent or carer.
Persisting parental suspicion of food allergy (especially in children with difficult or perplexing symptoms) despite a lack of supporting history.
Clinical suspicion of multiple food allergies.
If there is likely to be a delay in the child getting seen by secondary or specialist care, seek advice from a paediatric dietician regarding prescribing a
hypoallergenic formula in the interim.
If referral is not indicated, advise a trial elimination of cows' milk from the diet for between 26 weeks, followed by reintroduction of cows' milk to
prove that it is the cause of symptoms. Seek advice from (or refer the person to) a paediatric dietitian with appropriate competencies for guidance on
nutritional adequacies, timings of elimination and reintroduction, and follow up.
In exclusively breastfed babies, advise the mother to exclude cows' milk protein from her diet. Consider prescribing a daily supplement of 1000 mg of
calcium and 10 micrograms of vitamin D to the mother to prevent nutritional deficiencies.
In formula-fed or mixed-fed infants, advise the parents or carers to replace cows milk-based formula with hypoallergenic infant formulas (/cowsmilk-protein-allergy-in-children#!scenarioclarification), such as extensively hydrolysed formulas (tolerated by 90% of children with cows milk protein allergy) or
amino acid formulas. A paediatric dietician can advise on the appropriate milk formula to prescribe.
In weaned infants and older children, advise the parents or carers to exclude cows' milk protein from the child's diet. A paediatric dietician can give advice
to ensure that adequate intakes of all nutrients are provided by solid foods and liquids free from cows' milk.
If symptoms do not improve despite strict adherence to the elimination diet, refer the child to secondary or specialist care as other foods (for example
soya) may also need to be eliminated.
If symptoms improve, reintroduce cows' milk into the diet and monitor. If symptoms recur, cows' milk protein allergy can be confirmed. See Scenario:
Confirmed cows' milk protein allergy (/cows-milk-protein-allergy-in-children#!scenario:1) for information on how to manage confirmed cows' milk protein
allergy.
Ensure that the person is provided with appropriate information, taking into account socioeconomic, cultural, and religious issues. This should include
information on:
Non-IgE-mediated cows' milk protein allergy, including information on what it is and the potential risk of severe allergic reaction.
The elimination diet, including the safety and limitations, what foods and drinks to avoid, and the most appropriate hypoallergenic formula or milk substitute
(/cows-milk-protein-allergy-in-children#!scenarioclarification) for formula or mixed-fed babies.
How to interpret food labels.
Alternative sources of nutrition to ensure adequate nutritional intake.
Information and support groups, for example Allergy UK (http://www.allergyuk.org/milk-allergy/milk-allergy) (www.allergyuk.org) and CMPA Support
(http://cowsmilkproteinallergysupport.webs.com/) (www.cmpasupport.org.uk).
The British Dietetic Association (BDA) has produced a useful fact sheet (pdf) (https://www.bda.uk.com/foodfacts/milkallergy.pdf) on how to follow a healthy,
balanced, and milk-free diet.

Hypoallergenic infant formulas

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Extensively hydrolysed formulas (eHFs) are whey or casein based formulas that are tolerated by the majority of infants and children (90%) with cows' milk
protein allergy. They are based on cows milk but are extensively broken down into smaller peptides that are less well recognized by the immune system

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[Ludman et al, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807)].


Examples of eHFs prescribable on an FP10 include [Wood and Ieriti, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807); Baker et al, 2014
(/cows-milk-protein-allergy-in-children#!references/-617807)]:
Alimentum suitable from birth
Althera suitable from birth
Aptamil Pepti 1 suitable from birth
Aptamil Pepti 2 suitable from 6 months of age
Cow and Gate Pepti-Junior suitable from birth
Nutramigen Lipil 1 suitable from birth
Nutramigen Lipil 2 suitable from 6 months of age
Pregestimil Lipil suitable from birth
Amino acid formulas (AAFs) are an alternative for children who cannot tolerate eHFs, or those with severe symptoms [Baker et al, 2014 (/cows-milk-proteinallergy-in-children#!references/-617807)].
Examples of AAFs prescribable on an FP10 include [Wood and Ieriti, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807); Baker et al, 2014
(/cows-milk-protein-allergy-in-children#!references/-617807)]:
Alfamino suitable from birth
Neocate LCP suitable from birth
Neocate Active suitable from 1 year of age
Neocate Advance suitable from 1 year of age for children who cannot eat any other foods
Nutramigen Puramino suitable from birth
Soya proteinbased formulas (for example Wysoy) are not suitable as first-line products for cows' milk protein allergy treatment. However, following expert
advice from a clinician experienced in allergy management, they can be used in some children over 6 months of age who have been shown to have no soya
allergy.
Soya proteinbased formulas should not usually be used during the first 6 months of life because [Caffarelli et al, 2010 (/cows-milk-protein-allergyin-children#!references/-617807); Ludman et al, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807); Venter et al, 2013 (/cows-milk-proteinallergy-in-children#!references/-617807)]:
The absorption of minerals and trace elements may be lower because of their phytate content.
They contain appreciable amounts of isoflavones with a weak oestrogenic action that can lead to high serum concentrations in infants.
Other milk substitutes
Rice milk is not advised before the age of 4.5 years. Ready-made soya, pea, oat, coconut, or other milk substitutes may be used after 2 years of age, but the
choice will depend on the child's nutritional status and other allergies. A brand fortified with calcium should be used where possible [Baker et al, 2014 (/cowsmilk-protein-allergy-in-children#!references/-617807)].
Other mammalian milk proteins (including unmodified cow, sheep, buffalo, horse, or goats' milk) are not recommended for infants with cows' milk protein
allergy. This is because [Vandenplas et al, 2007 (/cows-milk-protein-allergy-in-children#!references/-617807); Ludman et al, 2013 (/cows-milk-protein-allergyin-children#!references/-617807)]:
They are not adequately nutritious to provide the sole food source for infants.
There is a risk of possible allergenic cross-reactivity with milk or formulas based on other mammalian milk proteins.

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Basis for recommendation

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These recommendations are largely based on the National Institute for Health and Care Excellence (NICE) guideline Food allergy in children and young people.
Diagnosis and assessment of food allergy in children and young people in primary care and community settings[NICE, 2011 (/cows-milk-protein-allergyin-children#!references/-617807)].
When to consider referral to secondary or specialist care
NICE reviewed the evidence to determine at which stage children with non-immunoglobulin E (IgE)-mediated food allergies should be referred to secondary or
specialist care [NICE, 2011 (/cows-milk-protein-allergy-in-children#!references/-617807)].
Evidence from low-quality studies formed the basis of the NICE referral criteria.
The NICE guideline development group (GDG) agreed that having some symptoms or conditions alone would not warrant referral; however, having symptoms
in combination with other factors would warrant consideration of referral.
Elimination diet for diagnosing cows' milk protein allergy
NICE reviewed the evidence on the cows' milk protein elimination diet for diagnosing non-IgE-mediated food allergies in children and young people [NICE, 2011
(/cows-milk-protein-allergy-in-children#!references/-617807)].
Although the evidence was of low quality, the NICE GDG felt that a well managed and supervised food elimination and reintroduction diet (following a
thorough allergy-focused clinical history (/cows-milk-protein-allergy-in-children#!diagnosissub:1)) was a sensible way to diagnose non-IgE-mediated food
allergy. Evidence was very poor in addressing food elimination for various age groups, but the GDG felt that the principle of food elimination would be
applicable to all age groups.
Paediatric dietician input
The NICE GDG discussed the competencies needed by healthcare professionals to oversee the elimination diet [NICE, 2011 (/cows-milk-protein-allergyin-children#!references/-617807)]. It was agreed that the elimination diet can be initiated in primary care; however, a dietician should be involved in the process
because it would reduce the time to diagnosis, and the dietician would be able to offer advice on nutritional issues, follow up, and the appropriate milk formula
for bottle-fed babies. It was thought that this would lead to reduced GP visits and hence reduced waste of NHS resources.
This recommendation is in line with expert opinion in review articles on the management of cows' milk protein allergy [Caffarelli et al, 2010 (/cows-milk-proteinallergy-in-children#!references/-617807); Ludman et al, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807)]; a European guideline, Diagnostic
Approach and Management of Cows-Milk Protein Allergy in Infants and Children: ESPGHAN GI Committee Practical Guidelines[Koletzko et al, 2012 (/cowsmilk-protein-allergy-in-children#!references/-617807)]; a consensus guideline, Guidelines for the diagnosis and management of cow's milk protein allergy in
infants[Vandenplas et al, 2007 (/cows-milk-protein-allergy-in-children#!references/-617807)]; and a fact sheet produced by the British Dietetic Association [Baker
et al, 2014 (/cows-milk-protein-allergy-in-children#!references/-617807)].
Observational and cohort studies have shown malnutrition in children on exclusion diets and children with newly diagnosed food allergies. These children
require dietetic input to ensure that this is managed or averted. Obesity can also be present in children on exclusion diets [Ludman et al, 2013 (/cowsmilk-protein-allergy-in-children#!references/-617807)].

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Calcium and vitamin D supplementation for breastfeeding mothers


The recommendation to consider prescribing calcium and vitamin D to mothers of exclusively breastfed babies is based on expert opinion in Guidelines for the
diagnosis and management of cow's milk protein allergy in infants[Vandenplas et al, 2007 (/cows-milk-protein-allergy-in-children#!references/-617807)] and in a
review article on the management of cows' milk protein allergy [Ludman et al, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807)], and aims to
reduce the risk of nutritional deficiencies.
Hypoallergenic milk formulas are formulated to provide the same nutrition as cows' milk, so additional supplementation may not be required for formula-fed
infants [Baker et al, 2014 (/cows-milk-protein-allergy-in-children#!references/-617807)].
For weaned infants and older children, a dietician can give advice to ensure that adequate intakes of all nutrients are provided during the elimination diet
[Koletzko et al, 2012 (/cows-milk-protein-allergy-in-children#!references/-617807)].
Managing children whose symptoms do not improve despite strict adherence to the elimination diet
This recommendation is pragmatic and is supported by expert reviewers of this CKS topic.
Children whose symptoms do not improve after strict adherence to the elimination diet should be assessed by a specialist because they may have multiple food
allergies (for example cows' milk protein allergy and a soya allergy), in which case other foods may also need to be eliminated.
Providing information and advice
NICE reviewed the evidence on information needs for children and young people with food allergies [NICE, 2011 (/cows-milk-protein-allergyin-children#!references/-617807)].
Although the evidence found was limited and did not fully address the clinical question, the NICE GDG agreed that the healthcare professional should tailor
most of the information to the specific needs and background of the child.
NICE also advises that parents and/or carers of children with suspected food allergy should be provided with appropriate information on the potential impact of
the suspected allergy on other healthcare issues, including vaccination [NICE, 2011 (/cows-milk-protein-allergy-in-children#!references/-617807)]. However, the
expert reviewers of this CKS topic agree that there are currently no vaccines affected by cows' milk protein allergy.
Other tests not recommended
Serum specific IgG tests: although no specific evidence was reviewed, the NICE GDG agreed that serum specific IgG tests are not appropriate for the
diagnosis and assessment of food allergy.
Vega testing, applied kinesiology, and hair analysis: due to the lack of evidence for these tests, and the lack of well-designed studies, the NICE GDG agreed
that they are not appropriate for diagnosing food allergy.
Skin prick tests and specific IgE measurements: expert opinion in a review article on the management of cows' milk protein allergy in children suggests that
these tests are of little use if non-IgE-mediated cows' milk protein allergy is suspected [Ludman et al, 2013 (/cows-milk-protein-allergy-in-children#!references
/-617807)].
Atopy patch tests: although NICE found evidence that the atopy patch test may be useful in the diagnosis of non-IgE-mediated food allergy, the NICE GDG felt
that it was less well-standardized and more variable than other tests. The group also felt that the results may not be directly applicable to the primary care
population as the studies reviewed were all conducted in secondary or specialist settings, where the test may have been performed more effectively.
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Scenario: Confirmed cows' milk protein allergy


Age from 0 months to 5 years

Managing confirmed cows' milk protein allergy

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How should I manage a child with confirmed cows' milk protein allergy?
Strict avoidance of cows' milk protein is currently the safest strategy for managing cows' milk protein allergy.
Children with immunoglobulin E (IgE)-mediated cows' milk protein allergy are usually managed in secondary care.
Provided referral (/cows-milk-protein-allergy-in-children#!scenariorecommendation:1/-617831) is not indicated, children with non-IgE-mediated cows'
milk protein allergy can be managed in primary care with input from a paediatric dietician. Management includes:
Implementing a strict cows' milk elimination diet for at least 6 months or until the child is 912 months old.
In exclusively breastfed babies, advise the mother to exclude cows' milk protein from her diet. Consider prescribing a daily supplement of 1000 mg of
calcium and 10 micrograms of vitamin D to the mother to prevent nutritional deficiencies.
In formula-fed or mixed-fed infants, advise the parents or carers to replace cows milk-based formula with hypoallergenic infant formulas (/cowsmilk-protein-allergy-in-children#!scenarioclarification:1), such as extensively hydrolysed formulas (tolerated by 90% of children with cows milk protein
allergy) or amino acid formulas. A paediatric dietician can advise on the appropriate milk formula to prescribe.
In weaned infants and older children, advise the child and/or parents or carers to exclude cows' milk protein from the child's diet. A paediatric dietician
can give advice to ensure that adequate intakes of all nutrients are provided by solid foods and liquids free from cows' milk.
Nutritional counselling and regular monitoring of growth.
Seek advice from (or refer the person to) a paediatric dietitian with appropriate competencies for guidance on nutritional adequacies and follow up.
If access to a dietician is not possible in primary care, monitor the child's height and weight regularly to assess growth and nutrition.
Re-evaluation of the child to assess tolerance to cows' milk protein.
The child should be evaluated every 6 to 12 months to assess whether they have developed a tolerance to cows' milk protein. This can be done at home
provided there are no indications for referral (/cows-milk-protein-allergy-in-children#!scenariorecommendation:1/-617831) to secondary care, for example
one or more acute systemic reactions.
This involves reintroducing cows' milk into the diet and monitoring for the return of symptoms. The parents or carers should be advised to start the
reintroduction with baked milk products (such as muffins, cakes, and malted milk biscuits) as they are less allergenic.
If symptoms return, the elimination diet should be continued and the child should be re-evaluated after a further 6 to 12 months.
Once tolerance is established, greater exposure of less processed milk should be gradually encouraged, as advised in the 'Milk Ladder' (several versions of
the Milk Ladder are freely available online, for example The Map Guideline Milk Ladder (pdf) (http://ifan.ie/wp-content/uploads/2014/02/Milk-Ladder2013-MAP.pdf)).
A paediatric dietician can advise on timings of elimination and reintroduction of cows' milk.
Ensuring that the person is provided with appropriate information, taking into account socioeconomic, cultural, and religious issues. This should
include information on:
The elimination diet, including the safety and limitations, what foods and drinks to avoid, and the most appropriate hypoallergenic formula or milk substitute

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(/cows-milk-protein-allergy-in-children#!scenarioclarification) for formula or mixed-fed babies. The British Dietetic Association (BDA) has produced a useful
fact sheet (pdf) (https://www.bda.uk.com/foodfacts/milkallergy.pdf) on how to follow a healthy, balanced, and milk-free diet.
How to interpret food labels.
Alternative sources of nutrition to ensure adequate nutritional intake.
Support groups, for example Allergy UK (http://www.allergyuk.org/milk-allergy/milk-allergy) (www.allergyuk.org) and CMPA Support
(http://cowsmilkproteinallergysupport.webs.com/) (www.cmpasupport.org.uk).

Hypoallergenic infant formulas

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Extensively hydrolysed formulas (eHFs) are whey or casein based formulas that are tolerated by the majority of infants and children (90%) with cows' milk
protein allergy. They are based on cows milk but are extensively broken down into smaller peptides that are less well recognized by the immune system
[Ludman et al, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807)].
Examples of eHFs prescribable on an FP10 include [Wood and Ieriti, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807); Baker et al, 2014
(/cows-milk-protein-allergy-in-children#!references/-617807)]:
Alimentum suitable from birth
Althera suitable from birth
Aptamil Pepti 1 suitable from birth
Aptamil Pepti 2 suitable from 6 months of age
Cow and Gate Pepti-Junior suitable from birth
Nutramigen Lipil 1 suitable from birth
Nutramigen Lipil 2 suitable from 6 months of age
Pregestimil Lipil suitable from birth
Amino acid formulas (AAFs) are an alternative for children who cannot tolerate eHFs, or those with severe symptoms [Baker et al, 2014 (/cows-milk-proteinallergy-in-children#!references/-617807)].
Examples of AAFs prescribable on an FP10 include [Wood and Ieriti, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807); Baker et al, 2014
(/cows-milk-protein-allergy-in-children#!references/-617807)]:
Alfamino suitable from birth
Neocate LCP suitable from birth
Neocate Active suitable from 1 year of age
Neocate Advance suitable from 1 year of age for children who cannot eat any other foods
Nutramigen Puramino suitable from birth
Soya proteinbased formulas (for example Wysoy) are not suitable as first-line products for cows' milk protein allergy treatment. However, following expert
advice from a clinician experienced in allergy management, they can be used in some children over 6 months of age who have been shown to have no soya
allergy.
Soya proteinbased formulas should not usually be used during the first 6 months of life because [Caffarelli et al, 2010 (/cows-milk-protein-allergyin-children#!references/-617807); Ludman et al, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807); Venter et al, 2013 (/cows-milk-proteinallergy-in-children#!references/-617807)]:
The absorption of minerals and trace elements may be lower because of their phytate content.

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They contain appreciable amounts of isoflavones with a weak oestrogenic action that can lead to high serum concentrations in infants.
Other milk substitutes
Rice milk is not advised before the age of 4.5 years. Ready-made soya, pea, oat, coconut, or other milk substitutes may be used after 2 years of age, but the
choice will depend on the child's nutritional status and other allergies. A brand fortified with calcium should be used where possible [Baker et al, 2014 (/cowsmilk-protein-allergy-in-children#!references/-617807)].
Other mammalian milk proteins (including unmodified cow, sheep, buffalo, horse, or goats' milk) are not recommended for infants with cows' milk protein
allergy. This is because [Vandenplas et al, 2007 (/cows-milk-protein-allergy-in-children#!references/-617807); Ludman et al, 2013 (/cows-milk-protein-allergyin-children#!references/-617807)]:
They are not adequately nutritious to provide the sole food source for infants.
There is a risk of possible allergenic cross-reactivity with milk or formulas based on other mammalian milk proteins.

Basis for recommendation

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The National Institute for Health and Care Excellence (NICE) guideline Food allergy in children and young people. Diagnosis and assessment of food allergy in
children and young people in primary care and community settings[NICE, 2011 (/cows-milk-protein-allergy-in-children#!references/-617807)] does not cover the
management of children and young people with confirmed cows' milk protein allergy. These recommendations are therefore largely based on expert opinion in
guidelines and review articles on the management of cows' milk protein allergy in children [Vandenplas et al, 2007 (/cows-milk-protein-allergyin-children#!references/-617807); Caffarelli et al, 2010 (/cows-milk-protein-allergy-in-children#!references/-617807); Koletzko et al, 2012 (/cows-milk-protein-allergyin-children#!references/-617807); Ludman et al, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807); Venter et al, 2013 (/cows-milk-protein-allergyin-children#!references/-617807)].
Elimination diet for managing cows' milk protein allergy
Expert opinion in guidelines and review articles on the management of cows' milk protein allergy in children suggests that strict avoidance of cows' milk protein is
currently the safest strategy for managing cows' milk protein allergy [Vandenplas et al, 2007 (/cows-milk-protein-allergy-in-children#!references/-617807);
Caffarelli et al, 2010 (/cows-milk-protein-allergy-in-children#!references/-617807); Koletzko et al, 2012 (/cows-milk-protein-allergy-in-children#!references
/-617807); Ludman et al, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807); Venter et al, 2013 (/cows-milk-protein-allergy-in-children#!references
/-617807)]. The child's diet (or maternal diet for exclusively breastfed babies) should be free from cows' milk protein until an oral challenge indicates the
development of tolerance [Koletzko et al, 2012 (/cows-milk-protein-allergy-in-children#!references/-617807)].
Although the NICE guideline on food allergy [NICE, 2011 (/cows-milk-protein-allergy-in-children#!references/-617807)] does not cover the management of
children and young people with confirmed cows' milk protein allergy, it states that 'food elimination represents not only a diagnostic tool for food allergy but also
its treatment. If someone has a suspected food allergy they will be put on a food elimination diet. If the allergy is confirmed by their symptoms improving, the diet
is continued as treatment' [NICE, 2011 (/cows-milk-protein-allergy-in-children#!references/-617807)].
Management of confirmed immunoglobulin E (IgE)-mediated cows' milk protein allergy
Although the NICE guideline on food allergy [NICE, 2011 (/cows-milk-protein-allergy-in-children#!references/-617807)] does not cover the management of

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children and young people with confirmed cows' milk protein allergy, it states that diagnostic tests for suspected IgE-mediated cows' milk protein allergy 'should
only be undertaken by healthcare professionals with the appropriate competencies to select, perform and interpret them' [NICE, 2011 (/cows-milk-protein-allergyin-children#!references/-617807)]. CKS recognizes that the expertise to choose, perform, and interpret these tests may not be readily available in primary care;
therefore, the diagnosis and subsequent management of cows' milk protein allergy is more likely to be done in secondary care.
In addition, children and young people with confirmed IgE-mediated cows' milk protein allergy are more likely to have an anaphylactic reaction (especially if they
also have asthma) [Koletzko et al, 2012 (/cows-milk-protein-allergy-in-children#!references/-617807); Ludman et al, 2013 (/cows-milk-protein-allergyin-children#!references/-617807)]. It is therefore safer that these children are managed in secondary care.
Management of confirmed non-IgE-mediated cows' milk protein allergy
Expert opinion in review articles on the management of cows' milk protein allergy in children suggests that provided referral (/cows-milk-protein-allergyin-children#!scenariorecommendation:1) is not indicated, children with non-IgE-mediated cows' milk protein allergy can usually be managed in primary care with
dietetic input [Ludman et al, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807); Venter et al, 2013 (/cows-milk-protein-allergyin-children#!references/-617807)].
Paediatric dietician input
This recommendation is based on expert opinion in review articles on the management of cows' milk protein allergy [Caffarelli et al, 2010 (/cows-milk-proteinallergy-in-children#!references/-617807); Venter et al, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807); Ludman et al, 2013 (/cows-milk-proteinallergy-in-children#!references/-617807)]; a European guideline, Diagnostic Approach and Management of Cows-Milk Protein Allergy in Infants and Children:
ESPGHAN GI Committee Practical Guidelines[Koletzko et al, 2012 (/cows-milk-protein-allergy-in-children#!references/-617807)]; a consensus guideline,
Guidelines for the diagnosis and management of cow's milk protein allergy in infants[Vandenplas et al, 2007 (/cows-milk-protein-allergy-in-children#!references
/-617807)]; and a fact sheet produced by the British Dietetic Association (BDA) [Baker et al, 2014 (/cows-milk-protein-allergy-in-children#!references/-617807)].
Observational and cohort studies have shown malnutrition in children on exclusion diets and children with newly diagnosed food allergies. These children
require dietetic input to ensure that this is managed or averted. Obesity can also be present in children on exclusion diets [Ludman et al, 2013 (/cowsmilk-protein-allergy-in-children#!references/-617807)].
The role of the dietitian during the elimination diet cannot be underestimated, and includes providing advice on choice of formula, monitoring nutritional status,
and suggesting nutritional supplements and dietary advice for the breastfeeding mother and infant. Dietitians can also give invaluable advice on the level of
cows' milk allergen avoidance that is required (that is, which foods should be omitted and which foods can be tolerated), and provide written information on
suitable substitute foods, recipes, label reading, and lifestyle adjustments [Venter et al, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807)].
The recommendation to monitor height and weight if access to a dietician is not possible in primary care is based on expert opinion in a review article on the
management of cows' milk protein allergy [Ludman et al, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807)]. However, dietetic support is a better
and safer option.
Re-evaluation to assess tolerance to cows' milk protein
CKS did not find any evidence on the ideal time for testing for development of tolerance. However, experts agree that infants with a proven cows' milk protein
allergy should remain on a cows' milk protein free diet until 912 months of age and for at least 6 months prior to reintroduction of cows' milk into their diets
[Vandenplas et al, 2007 (/cows-milk-protein-allergy-in-children#!references/-617807); Caffarelli et al, 2010 (/cows-milk-protein-allergy-in-children#!references
/-617807); Koletzko et al, 2012 (/cows-milk-protein-allergy-in-children#!references/-617807); Ludman et al, 2013 (/cows-milk-protein-allergy-

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in-children#!references/-617807); Venter et al, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807)].


The recommendation to start the reintroduction with baked milk and to encourage greater exposure of less processed milk once tolerance is established is based
on a Milk Guideline Executive Summary produced by the British Society for Allergy and Clinical Immunology [Luyt et al, 2014 (/cows-milk-protein-allergyin-children#!references/-617807)].
In the expert opinion of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), continuation of the elimination diet when
the child may have already developed tolerance to cows' milk may impair growth and quality of life of both the child and their family, while incurring significant
unnecessary healthcare costs [Koletzko et al, 2012 (/cows-milk-protein-allergy-in-children#!references/-617807)].
Offering appropriate information
NICE reviewed the evidence on information needs for children and young people with suspected food allergies [NICE, 2011 (/cows-milk-protein-allergyin-children#!references/-617807)]. The evidence found was limited and did not fully address the clinical question. However, the NICE GDG agreed that the
healthcare professional should tailor most of the information to the specific needs and background of the child or young person.
CKS has extrapolated this recommendation to children with confirmed cows' milk protein allergy because offering appropriate information and advice is also
necessary at this stage of management.
NICE also advises that parents and/or carers of children and young people with suspected food allergy should be provided with appropriate information on the
potential impact of the suspected allergy on other healthcare issues, including vaccination [NICE, 2011 (/cows-milk-protein-allergy-in-children#!references
/-617807)]. However, the expert reviewers of the CKS topic agree that there are currently no vaccines affected by cows' milk protein allergy.

Search strategy

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Scope of search
A literature search was conducted for guidelines, systematic reviews and randomized controlled trials on primary care management of Cows' milk protein allergy,
with additional searches in the following areas:
food allergy
paediatric food allergy
Search dates
No fixed date October 2014
Key search terms
Various combinations of searches were carried out. The terms listed below are the core search terms that were used for Medline.Further details are available on
request.
exp/milk hypersensitivity, expl/food hypersensitivity
"cow$ milk allergy".tw OR "cow milk protein allergy"
Table 1 . Key to search terms.

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Search commands

Explanation

indicates a MeSh subject heading with all subheadings selected

.tw.

indicates a search for a term in the title or abstract

exp

indicates that the MeSH subject heading was exploded to include the narrower, more specific terms beneath it in the MeSH tree

indicates that the search term was truncated (e.g. wart$ searches for wart and warts)

Sources of guidelines
National Institute for Health and Care Excellence (NICE) (http://www.nice.org.uk)
Scottish Intercollegiate Guidelines Network (SIGN) (http://www.sign.ac.uk)
Royal College of Physicians (http://www.rcplondon.ac.uk/)
Royal College of General Practitioners (http://www.rcgp.org.uk/)
Royal College of Nursing (http://www.rcn.org.uk/development/practice/clinicalguidelines)
NICE Evidence (https://www.evidence.nhs.uk/topics/)
Health Protection Agency (http://www.hpa.org.uk)
National Guidelines Clearinghouse (http://www.guideline.gov)
Guidelines International Network (http://www.g-i-n.net)
TRIP database (http://www.tripdatabase.com)
GAIN (http://www.gain-ni.org/index.php/audits/guidelines)
Institute for Clinical Systems Improvement (http://www.icsi.org)
National Health and Medical Research Council (Australia) (http://www.nhmrc.gov.au/publications/index.htm)
Royal Australian College of General Practitioners (http://www.racgp.org.au/your-practice/guidelines/)
British Columbia Medical Association (http://www.health.gov.bc.ca/gpac/index.html)
Canadian Medical Association (http://www.cma.ca/index.php/ci_id/54316/la_id/1.htm)
Towards Optimal Practice (http://www.topalbertadoctors.org/cpgs/)
University of Michigan Medical School (http://ocpd.med.umich.edu/cme/self-study/)
Michigan Quality Improvement Consortium (http://www.mqic.org/guidelines.htm)
Patient UK Guideline links (http://www.patient.co.uk/guidelines.asp)
Driver and Vehicle Licensing Agency (https://www.gov.uk/government/organisations/driver-and-vehicle-licensing-agency)
Medline (with guideline filter)
Sources of systematic reviews and meta-analyses
The Cochrane Library (http://www.thecochranelibrary.com) :
Systematic reviews
Protocols
Database of Abstracts of Reviews of Effects
Medline (with systematic review filter)
EMBASE (with systematic review filter)

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Sources of health technology assessments and economic appraisals


The Cochrane Library (http://www.thecochranelibrary.com) :
NHS Economic Evaluations
Health Technology Assessments
Canadian Agency for Drugs and Technologies in Health (http://www.cadth.ca)
International Network of Agencies for Health Technology Assessment (http://www.inahta.org)
NIHR Health Technology Assessment programme (http://www.hta.ac.uk/)
Sources of randomized controlled trials
The Cochrane Library (http://www.thecochranelibrary.com) :
Central Register of Controlled Trials
Medline (with randomized controlled trial filter)
EMBASE (with randomized controlled trial filter)
Sources of evidence based reviews and evidence summaries
Central Services Agency COMPASS Therapeutic Notes (http://www.medicinesni.com/courses/type.asp?ID=CN)
Sources of national policy
Department of Health (https://www.gov.uk/government/organisations/department-of-health)
Health Management Information Consortium (HMIC)
Patient experiences
Healthtalkonline (http://www.healthtalkonline.org/)
BMJ - Patient Journeys (http://www.bmj.com/bmj-series/patient-journeys)
Patient.co.uk - Patient Support Groups (http://www.patient.co.uk/selfhelp.asp)
Sources of medicines information
The following sources are used by CKS pharmacists and are not necessarily searched by CKS information specialists for all topics. Some of these resources are
not freely available and require subscriptions to access content.
British National Formulary (http://www.evidence.nhs.uk/formulary/bnf/current) (BNF)
electronic Medicines Compendium (http://www.medicines.org.uk) (eMC)
European Medicines Agency (http://www.ema.europa.eu/ema/) (EMEA)
LactMed (http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT)
Medicines and Healthcare products Regulatory Agency (http://www.mhra.gov.uk/index.htm) (MHRA)
REPROTOX (http://www.reprotox.org/Default.aspx)
Scottish Medicines Consortium (http://www.scottishmedicines.org.uk/Home)
Stockley's Drug Interactions (https://www.medicinescomplete.com/mc/stockley/current/login.htm)
TERIS (http://depts.washington.edu/terisweb/teris/)
TOXBASE (http://www.toxbase.org/)
Micromedex (http://www.micromedex.com/products/hcs/)

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UK Medicines Information (http://www.ukmi.nhs.uk/)

Cows' milk protein allergy in children - Summary

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Cows' milk protein allergy is an immune-mediated allergic response to proteins in milk.


It is one of the most common childhood food allergies in the developed world, with the highest prevalence during the first year of life.
Cows' milk protein allergy is classified according to the underlying cause:
Immunoglobulin E (IgE)-mediated reactions are caused by the release of histamine and other mediators. The reactions are acute and frequently have a rapid
onset (up to 2 hours after milk ingestion).
Non-IgE-mediated reactions are thought to be caused by T-cells. The reactions are non-acute and generally delayed (manifest up to 48 hours or even 1 week
after milk ingestion).
More than half of children with IgE-mediated cows' milk protein allergy outgrow their milk allergy by 5 years of age. Most children with non-IgE-mediated cows'
milk allergy will be milk tolerant by 3 years of age.
Risk factors for developing cows' milk protein allergy include atopic comorbidities (such as asthma and eczema) and a family history of atopy.
Cows' milk protein allergy can induce a wide range of symptoms involving many different organ systems, mostly the skin (such as pruritus, urticaria, and angiooedema), gastrointestinal tract (such as nausea, vomiting, and colic), and the respiratory tract (such as cough, runny nose, and wheezing).
If cows' milk protein allergy is suspected in a child, an allergy-focused clinical history tailored to the presenting symptoms should be taken. The possibility of a
co-existing comorbidity (such as asthma or atopic eczema) or an alternative diagnosis (such as food intolerance or chronic constipation) should also be
considered.
Suspected IgE-mediated cows' milk protein allergy is confirmed by a skin prick and/or a specific IgE antibody blood test (previously known as a RAST test).
These tests may be performed in primary care if the expertise to conduct and interpret the test are available.
The decision to perform a skin prick test or a specific IgE antibody blood test in primary care should also be based on the results of the allergy-focused clinical
history and whether the test is available, suitable, safe, and acceptable to the child (or their parent or carer).
Suspected non-IgE-mediated cows' milk protein allergy is diagnosed by trial elimination of cows' milk from the child's diet (or maternal diet for exclusively
breastfed babies) normally for between 26 weeks, then reintroduction into the diet to confirm the diagnosis. This can be done in primary care with dietetic input
for nutritional counselling and advice on compliance with the elimination diet.
For suspected IgE and non-IgE-mediated cows' milk protein allergy, referral to secondary care should be considered if there is:
Faltering growth in combination with one or more gastrointestinal symptoms.
One or more acute systemic reactions.
One or more severe delayed reactions.
Significant atopic eczema where multiple or cross-reactive food allergies are suspected by the parent or carer.
Persisting parental suspicion of food allergy (especially in children with difficult or perplexing symptoms) despite a lack of supporting history.
A clinical suspicion of multiple food allergies.
Strict exclusion of cows' milk protein from the child's diet (or maternal diet for exclusively breastfed babies) is currently the safest strategy for managing
confirmed cows' milk protein allergy.
IgE-mediated cows' milk protein allergy is usually managed in secondary care.
Non-IgE-mediated cows' milk protein allergy can be managed in primary care with dietetic input.
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Have I got the right topic?


Age from 0 months to 5 years
This CKS topic covers the management of cows' milk protein allergy in children aged 5 years and younger.
This CKS topic does not cover the management of cows' milk protein allergy in older children and adults. This CKS topic also does not cover the management of
other types of food allergy, such as nut, wheat, soya, fish, and hens' egg allergies, or the management of food intolerance.
There are separate CKS topics on Asthma (/asthma), Angio-oedema and anaphylaxis (/angio-oedema-and-anaphylaxis), Dermatitis - contact (/dermatitis-contact),
Eczema - atopic (/eczema-atopic), and Urticaria (/urticaria).
The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary healthcare.

How up-to-date is this topic?

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Changes
Update

Goals and outcome measures

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Goals

Background information

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Definition
Causes
Prevalence
Risk factors
Prognosis
Complications

Diagnosis

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When to suspect

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Assessment
Differential diagnosis

Management

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Scenario: Suspected cows' milk protein allergy (/cows-milk-protein-allergy-in-children#!scenario) : covers the management of children and young people
with suspected cows' milk protein allergy.
Scenario: Confirmed cows' milk protein allergy (/cows-milk-protein-allergy-in-children#!scenario:1) : covers the management of children and young
people with confirmed cows' milk protein allergy.

How this topic was developed

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Search strategy

References

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Anand, M. (2014) Immediate hypersensitivity reactions.Medscape. emedicine.medscape.com [Free Full-text (http://emedicine.medscape.com/article/136217overview)]


Baker, G., Meyer, R. and Reeves, L. (2014) Food fact sheet: suitable milks for children with cow's milk allergy.The British Diabetic Association.
https://www.bda.uk.com/foodfacts/home#medical_conditions [Free Full-text (http://www.nhs.uk/ipgmedia/National/British%20Dietetic%20Association/assets
/MilksforChildrenwithaCowsMilkAllergy.pdf)]
Caffarelli, C., Baldi, F., Bendandi, B. et al. (2010) Cow's milk protein allergy in children: a practical guide.Italian Journal of Pediatrics36(5), . [Abstract
(http://www.ncbi.nlm.nih.gov/pubmed/20205781)] [Free Full-text (http://www.ijponline.net/content/36/1/5)]
Elizur, A., Rajuan, N., Goldberg, M. et al. (2012) Natural course and risk factors for persistence of IgE-mediated cow's milk allergy.Journal of Pediatrics161(3),
482-487. [Abstract (http://www.ncbi.nlm.nih.gov/pubmed/22480700)]
Fiocchi, A., Schunemann, H., Brozek, J. et al. (2010) Diagnosis and Rationale for Action Against Cow's Milk Allergy (DRACMA): a summary report.Journal of Allergy
and Clinical Immunology126(6), 1119-1128. [Abstract (http://www.ncbi.nlm.nih.gov/pubmed/21134569)]
Koletzko, S., Niggemann, B., Arato, A. et al. (2012) Diagnostic approach and management of cow's-milk protein allergy in infants and children: ESPGHAN GI
committee practical guidelines.Journal of Pediatric Gastroenterology and Nutrition55(2), 221-229. [Abstract (http://www.ncbi.nlm.nih.gov/pubmed/22569527)] [Free
Full-text (http://espghan.med.up.pt/position_papers/Diagnostic_Approach_and_Management_of_Cow_s_Milk.28.pdf)]
Ludman, S., Shah, N. and Fox, A. (2013) Managing cows' milk allergy in children (clinical review).BMJ347(), f5424.

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Luyt, D., Ball, H., Makwana, N. et al. (2014) Executive summary of BSACI guideline for the diagnosis and management of cow's milk allergy.British Society for
Allergy & Clinical Immunology (BSACI). http://www.bsaci.org/ [Free Full-text (http://www.bsaci.org/Guidelines/milk-allergy)]
Moissidis, I., Chaidaroon, D., Vichyanond, P. and Bahna, S. (2005) Milk-induced pulmonary disease in infants (Heiner syndrome).Pediatric Allergy and
Immunology16(6), 545-552. [Abstract (http://www.ncbi.nlm.nih.gov/pubmed/16176405)]
Motola, C. (2004) Disease summaries: food allergy.World Allergy Organization. www.worldallergy.org [Free Full-text (http://www.worldallergy.org/professional
/allergic_diseases_center/foodallergy/)]
NICE (2011) Food allergy in children and young people. Diagnosis and assessment of food allergy in children and young people in primary care and community
settings (full guideline). . Clinical guideline 116. National Institute for Health and Care Excellence. www.nice.org.uk [Free Full-text (http://www.nice.org.uk/guidance
/cg116/resources/cg116-food-allergy-in-children-and-young-people-full-guideline3)]
Saarinen, K., Pelkonen, A., Makela, M. and Savilahti, E. (2005) Clinical course and prognosis of cow's milk allergy are dependent on milk-specific IgE status.Journal
of Allergy and Clinical Immunology116(4), 869-875. [Abstract (http://www.ncbi.nlm.nih.gov/pubmed/16210063)]
Sicherer, S., Eigenmann, P. and Sampson, H. (1998) Clinical features of food protein-induced enterocolitis syndrome.Journal of Pediatrics133(2), 214-219. [Abstract
(http://www.ncbi.nlm.nih.gov/pubmed/9709708)]
Sicherer, S., Wood, R., Stablein, D. et al. (2010) Immunologic features of infants with milk or egg allergy enrolled in an observational study (consortium of food
allergy research) of food allergy.Journal of Allergy and Clinical Immunology125(5), 1077-1083. [Abstract (http://www.ncbi.nlm.nih.gov/pubmed/20451041)]
Swagerty, D.L., Walling, A.D. and Klein, R.M. (2002) Lactose intolerance.American Family Physician65(9), 1845-1850. [Abstract (http://www.ncbi.nlm.nih.gov
/pubmed/12018807)] [Free Full-text (http://www.aafp.org/afp/2002/0501/p1845.html)]
Vandenplas, Y., Brueton, M., Dupont, C. et al. (2007) Guidelines for the diagnosis and management of cow's milk protein allergy in infants.Archives of Disease in
Childhood92(10), 902-908. [Abstract (http://www.ncbi.nlm.nih.gov/pubmed/17895338)] [Free Full-text (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2083222/)]
Venter, C., Brown, T., Shah, N. et al. (2013) Diagnosis and management of non-IgE-mediated cow's milk allergy in infancy - a UK primary care practical
guide.Clinical and Translational Allergy3(1), 23. [Abstract (http://www.ncbi.nlm.nih.gov/pubmed/23835522)] [Free Full-text (http://www.ctajournal.com/content
/3/1/23)]
Wood, Z. and Ieriti, M. (2013) Paediatric nutritional products: appropriate prescribing resource pack. . 17th January 2013. NHS London Procurement Partnership.
https://www.lpp.nhs.uk

Supporting evidence
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The recommendations on the management of children with suspected cows' milk protein allergy are largely based on the National Institute for Health and Care
Excellence (NICE) guideline Food allergy in children and young people. Diagnosis and assessment of food allergy in children and young people in primary care
and community settings[NICE, 2011 (/cows-milk-protein-allergy-in-children#!references/-617807)].
For a detailed discussion of the evidence NICE used to base their recommendations, see the full NICE guidance (http://www.nice.org.uk/guidance/cg116
/resources/cg116-food-allergy-in-children-and-young-people-full-guideline3).
The recommendations on the management of children with confirmed cows' milk protein allergy are largely based on expert opinion in guidelines and review
articles on the management of cows' milk protein allergy in children [Vandenplas et al, 2007 (/cows-milk-protein-allergy-in-children#!references/-617807);
Caffarelli et al, 2010 (/cows-milk-protein-allergy-in-children#!references/-617807); Koletzko et al, 2012 (/cows-milk-protein-allergy-in-children#!references
/-617807); Ludman et al, 2013 (/cows-milk-protein-allergy-in-children#!references/-617807); Venter et al, 2013 (/cows-milk-protein-allergy-in-children#!references
/-617807)].

Copyright 2016 National Institute for Health and Care Excellence. All rights reserved.

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