GUIDANCE ON THE DIAGNOSIS AND MANAGEMENT OF
COW’S MILK ALLERGY
This guideline is an interim update to the January 2015 guidelines following a formal review of
the specialised infant formula products available for prescription, and in light of changes to
local phlebotomy services.
The guideline is designed as a toolbox1 to primarily support GP’s and Childrens Health Teams in
the differential diagnosis and management of cow’s milk allergy, although it is relevant to all
health professionals involved with patients suffering with potential food allergy.
This guideline provides information about:
 symptoms of food hypersensitivity
 how to confirm a diagnosis of cow’s milk allergy
 whether they require the use of specialised infant formula
 when, how and what to prescribe
 how to manage a child with cow’s milk allergy
 if and when the child needs to be referred to secondary or specialist dietetic care.
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
-1-
Contents
Cow’s Milk Allergy (CMA)
Background and Prevalence
Symptoms
Diagnosis:
- Non-IgE mediated CMA
- Bottle fed infants:
- Hypoallergenic formulas
- Introduction of hypoallergenic formulas
- Re-challenge to confirm diagnosis
- Breast fed infants
- Vitamin D and calcium supplementation
- Hypoallergenic formulas
- Re-challenge to confirm diagnosis
- IgE mediated CMA
Referral
Treatment
- Re-challenging later to determine tolerance
- Re-challenge at home
- Re-challenge in hospital
- On-going management of children with CMA
3
4-5
4-12
4-10
6-8
6
7
8
9-10
9
9-10
10
10-12
13-14
15-18
15-17
15-16
16-17
17-18
Soya-based Formula
19
References
20-21
Cow’s milk allergy care pathway:
-
For children served by GPs in Nottingham City CCG
22-24
Appendix 1 – Allergy focused clinical history assessment sheet
25-26
Appendix 2 – Checking food labels - First line dietary advice for parents
27-28
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
-2-
Cow’s Milk Allergy (CMA)
Background
Food allergy is an adverse immune response to a food. It can be classified into IgE mediated
(type 1) and non-IgE mediated (type 4) reactions.

IgE mediated reactions are acute and frequently have rapid onset.

Non-IgE mediated reactions are generally characterised by delayed and non-acute
reactions.
Both types of reactions can occur in the same individual and IgE mediated allergy can develop
in individuals with previous non-IgE mediated symptoms, particularly following a prolonged
period of complete allergen exclusion.
Food allergy should not be confused with food intolerance, which is a non-immunological
reaction that can be caused by enzyme deficiencies, such as a lactase deficiency in Lactose
Intolerance (LI).
Lactose intolerance is rare in children under 3 years of age, unless onset of symptoms coincides
with an episode of gastro-enteritis. Typical symptoms of lactose intolerance include loose,
watery stools, abdominal bloating and pain, increased flatus and nappy rash. If other
symptoms are present such as rashes, eczema, vomiting, constipation or the child is not growing
well, they are more likely to have cow's milk allergy, even if some of the symptoms resolve
following lactose exclusion2. Refer to guidance on lactose intolerance.
CMA has been shown to affect between 1.8-7.5% of infants in the first year of life and it is
suggested that clinicians should anticipate that between 2-3 % of children have a CMA3. CMA
can develop in exclusively and partially breast-fed infants, as well as in bottle-fed infants and
when cow’s milk is introduced at weaning.
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
-3-
Symptoms of food allergy
Allergy to cow’s milk protein should be suspected in infants who present with any of the
symptoms listed in the following table (Table 1), in association with the introduction of cow’s
milk into their diet. The risk of atopy increases if a parent or sibling has atopic disease (20–40%
and 25–35%, respectively), and is higher still if both parents are atopic (40–60%)4.
NICE guidelines5 and subsequent NICE Food Allergy Quality Standards6 recommend that if food
allergy from any cause is suspected, then an allergy focused clinical history should be taken,
including family history of atopy and a physical examination conducted by a GP or other
competent medical personnel (see Appendix 1).
Diagnosis
Diagnosis of non-IgE mediated cow’s milk allergy
Diagnosis of non-IgE mediated CMA can be made if symptoms resolve after 2-6 weeks on a
cow’s milk elimination diet5-6. In children suffering from moderate to severe eczema, the
exclusion trial period is suggested to be between 6-8 weeks7. However, unless highly confident
of the response to the elimination diet (parents often describe them as being a different child)
or in infants who have had an extensive period of distressing symptoms prior to final resolution,
a firm diagnosis can only be made if re-occurrence of symptoms has been demonstrated
following a cow’s milk re-challenge5-6 (see Table 4). This re-challenge should not be done in
children who are thought to have acute IgE mediated allergy. In those with more severe,
distressing symptoms, resolution of symptoms can be accepted as diagnostic, with first rechallenge occurring at 1 year of age, as outlined under treatment (p15-17).
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
-4-
Table 1 Symptoms of food allergy5
IgE- mediated
Non-IgE-mediated
The Skin
Pruritus
Pruritus
Erythema
Erythema
Acute urticaria (localised/ generalised)
Unexplained skin rashes
Acute angioedema (commonly lips, face & eyes)
Moderate to severe atopic eczema
Acute flaring of atopic eczema
The Gastrointestinal system (GI)
Angioedema of lips, tongue & palate
Gastro-oesophageal reflux disease
Oral pruritus
Vomiting
Nausea
Loose or frequent stools
Vomiting
Blood and/or mucus in stools
Colicky abdominal pain
Abdominal distension and pain
Diarrhoea
Infantile colic
Food refusal or aversion
Constipation
Perianal redness or nappy rash
Pallor and tiredness
Faltering growth plus one or more gastrointestinal
symptoms (with/ without significant atopic
eczema)
The Respiratory System (usually in combination with one or more of the above symptoms and signs)
Upper respiratory tract symptoms – nasal itching,
Upper and lower ‘Catarrhal’ airway symptoms
sneezing, rhinorrhoea or congestion (with/ without
conjunctivitis)
Lower respiratory tract symptoms (cough, chest tightness, wheezing or shortness of breath)
Other
Signs or symptoms of anaphylaxis or other systemic
allergic reactions
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
-5-
Bottle-fed infants
If the mother is NOT breastfeeding exclusively, a hypoallergenic formula should be prescribed.
There are two types of hypoallergenic formula and the initial formula of choice will depend
upon the severity of presenting symptoms as outlined in Table 2.
Table 2 Hypoallergenic formulas to treat CMA in Nottinghamshire
Severity
of CMA
Presenting symptoms
Type of formula
Mild/
For the majority of
gastrointestinal and atopic
symptoms of cow’s milk
allergy
Extensively
Hydrolysed Infant
Formula (EHF):
Moderate
Recommended product
1st Line: Nutramigen 1 with
LGG or Nutramigen 2 with
LGG (MJ Nutrition) (> 6
st
1 line – casein based, months age) (£10.87 for
400g tin)
lactose free
2nd line – whey based
with lactose
Severe
Faltering growth, severe
infantile eczema, multiple
food allergies, reactions to
breast milk, iron deficiency
anaemia due to GI blood
loss, anaphylaxis,
respiratory difficulties,
other systemic reactions to
trace amounts of allergen
2nd Line:
SMA Althera
(£10.68 for 450g tin)
Amino Acid Infant 1st line: Neocate LCP
Formula (AAF)
(£28.30 for 400g tin) or
Neocate Active (Nutricia) (>
12 months age) (£66.60 for
15x63g sachets)
Second line EHF may be preferable for infants over 6 months due to palatability. If they still
have symptoms on Neocate LCP, they should be referred to a paediatrician. An alternative AAF
(SMA Alfamino or Nutramigen Puramino) could be tried while awaiting assessment, if cow’s
milk allergy is still suspected.
It is suggested in the first instance that approximately 1 weeks supply is prescribed i.e. 2 x 400g
tins or 1 x 800g tin, to ensure the product is tolerated.
Monthly prescriptions of hypoallergenic formula are expected to comprise of approximately
10-12 x 400-450g tins. This should reduce as solid intake increases.
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
-6-
Introduction of Hypoallergenic formula (HAF)
Due to the unpalatable taste of HAF, it is recommended in non-IgE mediated, delayed allergic
reactions to grade the children onto it. The rate that this is done will depend upon their age
(Table 3). This promotes acceptance and ensures tolerance of the product. Older children
(over 6 months) are more likely to accept the more palatable lactose containing EHF.
Table 3
Suggested grading procedure onto HAF
(print off for parent/ carer & highlight relevant section)
Age
Suggested grading procedure onto HAF
No. scoops to 6floz
(180ml) water
Existing
formula
< 10
weeks
Day 1: 50:50 mix of HAF with existing formula
Day 2: All HAF
10-20
weeks
HAF
3
3
Grade onto HAF formula in 2floz increments/
bottle/ day with existing formula
Day 1
Day 2
Day 3
4
2
0
2
4
6
> 20
weeks
Grade onto HAF formula in 1floz increments/
bottle/ day with existing formula
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
5
4
3
2
1
0
1
2
3
4
5
6
>6
months
As for > 20 weeks, but may need to increase in
1-3tsp increments (5-15ml)/ bottle/ day if refuses
Once the 2-6 week exclusion trial is completed, the child’s symptoms should be reviewed. If
they continue to suffer from symptoms after 2 weeks on an extensively hydrolysed formula,
they should try an amino acid formula (AAF) (Table 2). If they still have symptoms on an AAF,
they should be referred to a paediatrician. An alternative AAF (SMA Alfamino or Nutramigen
Puramino) could be tried while awaiting assessment, if cow’s milk allergy is still suspected.
Otherwise they should return to normal formula.
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
-7-
For children taking solids
If the child is already taking solids, they will need to adopt a strict cow’s milk free diet. First line
information on cow’s milk exclusion is available for the family in Appendix 2. More detailed
dietary information can be obtained via the community dietitians if required.
Re-challenge to confirm diagnosis in bottle fed babies
If symptoms have improved on the exclusion trial, to confirm the diagnosis in non-IgE mediated
allergy, children should be re-challenged with normal formula, or yogurt if taking solids (Table
4).
Table 4
Suggested diagnostic re-challenge procedure for non-IgE mediated CMA
(print off for parent/ carer)
Diagnostic re-challenge procedure
Day
If child is only taking formula
If child is taking solids
1
1tsp normal formula
1 tsp yogurt in morning
2
1floz normal formula in one morning
bottle only
2 tsp yogurt in morning
3
2floz normal formula in one morning
bottle only
4 tsp yogurt in morning
4
1floz normal formula/ bottle/ day
½ pot of yogurt during day
5+
Increase in 1floz increments/ bottle/
day (see table 3)
1 pot of yogurt during day
Then introduce other dairy foods followed by
gradually grading back onto normal infant
formula (as per Table 3 in reverse)
If the child’s symptoms return on re-challenge, they should resume the hypoallergenic formula
(HAF) and/ or strict milk free diet as soon as this occurs, and a referral made to a community
dietitian for further practical advice on following the cow’s milk free diet, to ensure nutritional
adequacy is maintained and to advise on future re-challenging and long term prescription
requirements6. It may be appropriate for children who have had a complicated path to
diagnosis and ultimately require an amino acid formula, to delay the re-challenge process until
1 year of age, assuming symptoms have satisfactorily resolved.
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
-8-
Breast fed babies
In a small number of exclusively breastfed infants, CMA can develop, as cow’s milk proteins
from the mother’s diet can pass into breast milk. These infants tend to be some of the most
allergic and are more likely to suffer from multiple food allergies. For these infants, mothers
should be encouraged to continue to breast feed while following a strict cow’s milk protein free
diet. For infants with severe eczema, a cow’s milk and egg free diet is recommended.
Breast feeding mothers have calcium requirements of 1250mg/ day and 10mcg vitamin D daily.
If breast feeding mothers are entitled to Healthy Start vitamins (providing 10mcg vitamin D),
they only require a calcium supplement;
Calcichew x 2 daily, providing 1000mg calcium
Otherwise they will need a combined calcium and vitamin D supplement;
Calcichew D3 x 2 daily will provide 1000mg calcium and 10mcg vitamin D
Liaison with a dietitian is recommended as more detailed dietary information than that
available in Appendix 2 is likely to be required. If mothers are unable to follow a milk-free diet
despite support from their GP, health visitor and dietitian, then careful consideration should be
given as to whether breast-feeding should continue and, if not, the infant will require an Amino
Acid Formula (AAF). They should not be given Extensively Hydrolysed Formula (EHF) as the
cow’s milk protein content is similar to that found in breast milk.
An emergency back-up supply of formula (AAF if exclusively breastfed, or EHF if partially breast
fed where reaction only occurred with introduction of standard formula top ups) should be
considered, in case of sudden breastfeeding failure due to illness etc.
The formula recommended to treat CMA in breast-fed babies in Nottinghamshire is:
-1st line: Neocate LCP (Nutricia) (£28.30 for 400g tin), Neocate Active (Nutricia) (£66.60 for
15x63g sachets) (>1 year of age)
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
-9-
If they still have symptoms on Neocate LCP, they should be referred to a paediatrician. An
alternative AAF (SMA Alfamino or Nutramigen Puramino) could be tried while awaiting
assessment, if cow’s milk allergy is still suspected.
Re-challenge to confirm diagnosis in breast fed babies
If symptoms have improved on the exclusion trial, to confirm the diagnosis in non-IgE mediated
allergy, breast fed children should be re-challenged by mum returning to a normal cow’s milk
containing diet. Referral should be made to a dietitian. If symptoms do not improve, the child
should be referred to a paediatrician.
Key prescribing points:

Initial prescription of 1 weeks supply i.e. 2 x 400g/ 450g tins, to ensure the product is
tolerated.
 Monthly prescriptions of hypoallergenic formula are expected to comprise of:
10-12 x 400-450g tins
 Once established on a HAF, prescriptions for the formula must be reviewed every 812 weeks for CMA to ensure continued improvement of symptoms.
 A ‘review’ or ‘stop’ date should be stated at the time of the initial prescription.
 Parents should be made aware from the beginning of how long the exclusion diet is
likely to be needed.
 Soya based formula should not be prescribed unless advised by a specialist.
Breastfeeding is supported as the best form of nutrition for a good start in life for every
child
Diagnosis of IgE mediated cow’s milk allergy
Children with suspected immediate IgE mediated reactions should be advised to adopt a strict
cow’s milk exclusion diet, which should be accompanied by resolution of symptoms (provide
the family with a copy of the BDA Milk Allergy fact sheet for interim first line advice on cow’s
milk avoidance, see Appendix 2). Unlike non-IgE mediated allergy, these children should not be
re-challenged with cow’s milk.
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
- 10 -
Nottinghamshire County CCG’s
All children with suspected IgE mediated cow’s milk allergy should be referred to secondary
care, for assessment and allergy testing as necessary.
Nottingham City CCG
In children suspected of multiple IgE mediated allergies, those with suspected IgE mediated
allergy and asthma, and in those at risk of anaphylaxis and other systemic reactions, the child
should be referred to secondary care for diagnostic assessment and allergy testing5-6.
All other patients should be referred to the specialist community paediatric allergy dietitian
(extended role) for support with implementing a cow’s milk free diet and for interpretation of
the IgE allergy test (see Table 5).
Children with suspected IgE mediated allergy require allergy sensitisation tests to confirm the
diagnosis5-6,8. Specific IgE to cow’s milk alongside a total IgE can be organised by Nottingham
City GPs by providing the patient with a blood form and informing patient of/ booking patient
into a paediatric phlebotomy service as follows:
Paediatric phlebotomy services for City CCG patients
 Children under 1 year - Childrens outpatient department, QMC:
Tel: 0115 924 9924 Ext 62661
 Children 1-4 years – CityCare Phlebotomy Service, Tel 0115 883 4880
Referral form to be completed by the GP and returned by email
[email protected] or by fax at 0115 884 4888
 Children 5-16 years – Parents to contact Clinical Assessment Service (CAS):
Tel 0115 883 3000 who will pass on details to chosen provider
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
- 11 -
The following table provides an insight into interpretation of specific IgE allergy testing,
although it is expected that the community allergy dietitian or other health professional with
appropriate competencies will explain the results to the family following receipt of referral.
Table 5 Interpretation of specific IgE to cow’s milk results (ImmunocapTM)
Specific IgE (Grade)*
Clinical implication for IgE cow’s milk allergy (CMA)
0 - 0.35 kU/L (Grade 0)
Considered to be IgE negative if <0.1 kU/L9. Supports
diagnosis of IgE mediated CMA if >0.1kU/L. More likely to
be non-IgE mediated if <0.1. If unexpected result, refer to
secondary care for skin prick testing
0.35 – 0.7 (Grade 1)
Supports diagnosis of IgE mediated CMA
0.7 – 3.5 (Grade 2)
Supports diagnosis of IgE mediated CMA
3.5 – 17.5 (Grade 3)
 2 yrs, 5kU/L has 95% positive predictive value for CMA4
> 2 yrs, 15kU/L has 95% positive predictive value for CMA
17.5 – 50 (Grade 4)
Very high levels can result from a high total IgE, but IgE
50 – 100 (Grade 5)
mediated CMA nevertheless highly likely
>100 (Grade 6)
*
Specific IgE results are only a measure of sensitisation and hence need to be interpreted in the
context of the allergy focused clinical history. They should not be used to predict the severity
of a clinical reaction, as systemic reactions can still occur at low, positive levels. Cow’s milk and
dairy products should therefore not be introduced to any child with a raised specific IgE to
cow’s milk (>0.1kU/L) without specialist support.
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
- 12 -
Referral
In accordance with NICE guidance5-6 relating to all forms of food allergy in children, referral to
secondary care should occur for on-going diagnostic assessment and management in infants
who have:
-
had a systemic allergic reaction (acute or delayed)
-
clinical/ parental suspicion of multiple IgE mediated reactions/ cross-reactions
-
strong clinical suspicion of IgE mediated food allergy but allergy test results are negative
-
IgE reactions to foods with a high risk of anaphylaxis e.g. tree nuts, peanuts, shellfish, kiwi,
sesame
-
confirmed IgE mediated food allergy and concurrent asthma
-
faltering growth or severe acute gastrointestinal reactions despite a cow’s milk exclusion
trial
If the infant does not have any of the above allergic manifestations associated with severe IgE
mediated or complex food allergy, then it is hoped that Nottingham City CCG GPs will feel
confident to diagnose and manage CMA with local expert community dietetic support, without
referral to secondary care. Referral to a paediatrician is indicated if the infant fails to respond
to dietary exclusion alone.
Referral to dietetic services across Nottinghamshire
Referral to registered paediatric dietitians in Nottinghamshire varies in light of differences in
commissioning and available local expertise in food allergy (Table 6).
Referral to a dietitian
with appropriate competencies is essential if a diagnosis has been confirmed, to ensure
nutritional adequacy, provide practical support; especially during weaning and in presence of
food avoidance issues, review appropriateness of prescribed products, advise on re-challenging
and ensure against unnecessary long-term exclusion of foods6.
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
- 13 -
Table 6 Referral to dietetic services across Nottinghamshire
Nottinghamshire CCG
Severity of cow’s milk allergy
Dietetic provider
Nottingham City

Nottingham CityCare
Partnership, Community
Nutrition and Dietetic Dept



South County CCGs 
(Rushcliffe, NE, NW)


Mid Notts CCGs



North Notts CCGs


All forms of non-IgE mediated
CMA
Mild to moderate IgE mediated
CMA (no systemic reactions or
comorbidity)
_____________
Severe IgE mediated CMA,
comorbidity/ high risk patients
Unresolving multiple non-IgE
mediated food allergy
_____________
NUH allergy clinic
paediatrician and dietitian
Mild/ moderate non-IgE mediated Nottinghamshire
Healthcare NHS Foundation
CMA
Trust, Community Nutrition
and Dietetic Dept
_____________
_____________
All forms of IgE mediated CMA
NUH
paediatrician
and
Severe CMA and multiple food
dietitian
allergies
Mild/ moderate non-IgE mediated Nottinghamshire
Healthcare NHS Foundation
CMA
Trust, Community Nutrition
and Dietetic Dept
_____________
_____________
Sherwood
Forest Hospitals
All forms of IgE mediated CMA
Severe CMA and multiple food paediatrician and dietitian
(Due to merge with NUH
allergies
hospitals)
All forms of non-IgE mediated Bassetlaw Hospital
paediatrician and dietitian
CMA
All forms of IgE mediated CMA
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
- 14 -
Treatment
Once the diagnosis has been confirmed i.e. they show improvement on a 2-6 week cow’s milk
elimination diet followed by deterioration on re-challenge (in non-IgE infants) or an
improvement with positive allergy sensitisation tests (in IgE infants), they should be given a
cow’s milk free diet for at least 6 months.
Babies should be weaned at the usual time onto a cow’s milk free diet and practical advice,
support and relevant literature will be provided by the dietitian on receipt of referral. Cow’s
milk and related products form a major food group which makes a significant contribution to
daily energy, protein, calcium, riboflavin and iodine intakes. Exclusion of this should therefore
not be taken lightly and it is essential that dietetic supervision is provided6.
Re-challenging at a later stage to determine tolerance
Children should be re-challenged after 6 months of cow’s milk (CM) exclusion, usually around
12 months of age to see if they have recovered. Whether the food challenge is done in hospital
or at home will depend upon the type and severity of the food allergy.
In infants diagnosed early in life (3-8 weeks of age) who have responded to Nutramigen with
LGG, it would be prudent to consider re-challenging around 6 months of age, to avoid potential
unnecessary elimination of dairy products from the weaning diet 10. In IgE mediated infants, rechallenging in the community would be considered on an annual basis and only following a
negative specific IgE to cow’s milk.
Cow’s milk challenge at home
If there is no anticipated risk of an acute reaction the challenge can be done at home i.e.
 the allergy is thought to be a non-IgE mediated, delayed onset pattern of symptoms
 or repeat specific IgE test is now negative
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
- 15 -
In infants with a strong personal/ family history of atopy however, particularly those with
moderate to severe eczema, an IgE sensitisation test to CM should be considered, to ensure
that their allergy has not evolved into IgE mediated allergy following an extended period of
complete CM avoidance3.
It is best to plan the challenge when the child is well and stable. Cow’s milk should gradually be
introduced, starting with small amounts in baked products as more severe reactions may occur
after a period of exclusion3. A cow’s milk re-challenge diet sheet is available from the dietitians
which should be adapted for each individual based on previous symptoms and whether they
have failed previous challenges. The child should already be under the care of a dietitian who
advises on this. If the re-challenge fails, it is essential that any child not under the dietitian is
subsequently referred to ensure nutritional adequacy, review appropriateness of prescribed
products, provide practical support, and advise on future re-challenging.
If the re-challenge around 12 months age is unsuccessful, then it should be repeated at 6
monthly intervals. Ingestion of small amounts of cow’s milk protein in baked foods if tolerated
should be encouraged, as it is thought to encourage development of future tolerance. It is not
however, appropriate to continue to include cow’s milk in the diet if it is causing untoward
reactions, and frequent re-challenging every few weeks to months can have a negative impact
upon the child’s well-being.
Cow’s milk challenge in hospital
If there has been an immediate-type respiratory reaction or anticipated risk of a severe
reaction, cow’s milk will need to be re-challenged in hospital. As it is not possible to predict the
severity of future reactions however, all children with a history of mild or moderate immediatetype reactions indicative of IgE mediated allergy should also be re-challenged in hospital, unless
previously positive specific IgE blood tests are now negative.
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
- 16 -
If the IgE sensitisation test is positive at 1 year of age, annual specific IgE tests to cow’s milk
should be undertaken, and CM re-challenge only done at home if the result is negative
(ImmunocapTM value of <0.1 kU/L). If by 3 years of age, specific IgE to CM is still positive, it
would be appropriate to refer them to secondary care for review, and a re-challenge in hospital
may be considered to determine whether the child is still symptomatic. The chance of reacting
clinically however, is still likely if the specific IgE to CM is > 15kU/L or > 5kU/L in infants < 2 yrs
(95% positive predictive value)8. A significant reduction in results over time appears to be
indicative of developing tolerance.
Ongoing management of children with CMA
Children with mild to moderate IgE mediated symptoms (those who have had only or mainly
cutaneous reactions on previous exposure) will need their IgE sensitisation status monitored on
an annual basis, and re-challenge only undertaken in the community if the tests are negative,
otherwise a supervised re-challenge with access to full resuscitation facilities will be required.
Ongoing prescription of specialised formula
All infants requiring hypoallergenic formula will continue to require monthly repeat
prescriptions until at least 1 year of age.
At 1 year of age, if soya is tolerated, a soya-based junior milk is available from supermarkets:
Alpro 1+ soya milk (1 litre cartons, known as giraffe milk due to picture on front). There are
currently no other milk substitutes available designed for children of 1-2 years of age.
Therefore, if there is any doubt about the nutritional adequacy of the child’s diet,
hypoallergenic formula should continue to be prescribed until 2 years of age.
Most children with non-IgE mediated allergy will have outgrown their allergy by 3-5 years of
age11, although IgE mediated CMA can persist into adolescence 12. The child should be given
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
- 17 -
further challenges with CM if still allergic at 5 years of age; annually until adulthood is reached
to ensure that the diet is not unnecessarily restrictive.
There needs to be a co-ordinated approach amongst GP’s, health professionals in both primary
and secondary care and parents/ carers including:

Monitoring of growth and nutrition on a 6-12 monthly basis

Identification and management of emerging comorbidities – GPs to conduct an annual
review of all children with CMA, including a physical examination and review of
medications relating to atopy/ allergies e.g. Epipens, asthma, eczema and rhinitis
medications, prescription of infant formulas and micronutrient supplements

Attempts to minimise the impact of having CMA on the quality of life

Dietetic supervision until at least 2 years of age, depending upon individual needs

Recognition of development of tolerance and appropriateness of re-challenging
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
- 18 -
Soya-based Formula
In 2004, the Chief Medical Officer issued a statement advising against the use of soya-based
formula in infants with cow’s milk protein allergy or lactose intolerance due to its phytooestrogen content, which could pose a risk to the long-term reproductive health of infants13.
There is also an increased risk of sensitisation to soya protein. Whilst only a small number of
children with IgE mediated CMA become sensitised to soya (10-14%), 30-64% of children with
non-IgE mediated CMA conditions such as enteropathy or enterocolitis can develop an allergy
to soya14.
Soya based formula should therefore not be prescribed unless advised by a competent health
professional. Parents wishing to feed their infant soya-based formula should be advised of the
risks and instructed to buy the formula over the counter rather than have it prescribed. Use of
soya formula should be limited to exceptional circumstances to ensure adequate nutrition, for
example, infants of vegan parents who are not breastfeeding. Where health professionals
consider it to be the most suitable alternative for the management of cow’s milk allergy or
galactosaemia in infants over 6 months of age, it should be prescribed as an alternative to
hypoallergenic formula.
Key Prescribing Points


Soya formula should not be used in infants with food allergy during the first 6 months
of life15.
Soya formula should not be used in infants suffering from moderate to severe gut
symptoms, which could be associated with cow’s milk induced enteropathy or
enterocolitis.14

A ‘review’ or ‘stop’ date should be stated at the time of the initial prescription

Parents should be made aware from the beginning of how long the exclusion diet is
likely to be needed
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
- 19 -
References
1. Lozinsky AC et al, 2015. Cow’s milk protein allergy from diagnosis to management: a very
different journey for General Practitioners and Parents. Children; 2: 317-329
2. Heyman M, 2006. Lactose intolerance in infants, children and adolescents. Pediatrics; 118
(3): 1279-1286
3. Luyt D et al, 2014. BSACI guideline for the diagnosis and management of cow’s milk allergy.
Clin Exp Allergy; 44: 642-672
4. Zieger RS, 2000. Dietary aspects of food allergy prevention in infants and children. J Pediatr
Gastroenterol Nutr; 30 (1) suppl: S36-S44
5. National Institute for Health and Clinical Excellence (NICE), 2011. Diagnosis and assessment
of food allergy in children and young people in primary care and community settings. NICE
clinical guideline 116. https://www.nice.org.uk/guidance/CG116
6. National Institute for Health and Clinical Excellence (NICE), 2016. Food Allergy. NICE
Quality Standard QS118. https://www.nice.org.uk/guidance/qs118
7. National Institute for Health and Clinical Excellence (NICE), 2007. Atopic eczema in children.
NICE clinical guideline 57. https://www.nice.org.uk/guidance/CG57
8. Du Toit G et al, 2009. The diagnosis of IgE–mediated food allergy in childhood. Pediatr
Allergy Immunol; 20: 309-319
9. Poza-Guedes P et al, 2016. Role of specific IgE to β-lactoglobulin in the gastrointestinal
phenotype of cow’s milk allergy. Allergy Asthma Clin Immunol; 12:7
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
- 20 -
10. Lazare FB et al, 2014. Rapid resolution of milk protein intolerance in infancy. J Pediatr
Gastroenterol Nutr; Mar 18 [Epub ahead of print]
11. Host A, 2002. Frequency of cow’s milk allergy in childhood. Ann Allergy Immunol; 89
(suppl): 33-37
12. Skripak J, Matsui EC, Mudd K & Wood R, 2007. The natural history of IgE-mediated cow’s
milk allergy. J Allergy Clin Immunol; 120: 1172-1177
13. Committee on Toxicity (COT), 2003. Phytoestrogens and Health Report. FSA: London
14. Bhatia J and Greer F, 2008.
Use of Soy Protein-based Formulas in Infant Feeding.
Pediatrics; 121:1062-1068
15. ESPGHAN Committee on Nutrition, 2006. Soy protein formulae and follow on formulae: A
commentary by the ESPGHAN Committee on Nutrition. J Ped Gastroenterol Nutr; 42 (4):
352-361
The revised document was reviewed by Dr Dinkar Bakshi (Paediatric Consultant, NUH), Dr
Michael Yanney (Paediatric Consultant, SFH), Debra Forster (Paediatric Nurse, QMC), Cerys
Gingell (Dietitian, QMC), Dr Esther Gladman (GP), Laura Catt (Prescribing Interface Advisor),
Helen Storer (Head of Nutrition and Dietetics, CityCare), Amy Freeman-Hughes (Dietitian, Kings
Mill), Amanda Roberts (Lay person for APC)
The following food allergy care pathway has been agreed for all families whose GP is part of the
Nottingham City Clinical Commissioning Group (CCG).
Food allergy care pathways have not yet been agreed for families with GP’s in other areas.
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Interim Update September 2016
- 21 -
Food allergy care pathway for
children under Nottingham City CCG
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Updated: September 2016
- 22 -
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Updated: September 2016
- 23 -
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Updated: September 2016
- 24 -
Appendix 1 - Allergy focused clinical history assessment sheet
Name:
DOB
NHS no.
If there is an immediate reaction to food resulting in breathing difficulties/ wheeze, lethargy or other systemic
symptoms, or a reaction to trace amounts of food, refer if appropriate to A&E or refer directly to secondary care. In
all other cases, use this sheet in liaison with a community paediatric dietitian.
Child’s History
Any atopic disease (eczema, asthma, hayfever)? …………………………………………………………………………………………….....
Any parental concerns around food allergy or intolerance?…………………………………................................................
Family History
Any atopic disease in parents or siblings (eczema, asthma, hayfever)? ………………………………………………………………..
………………………………………………………………………………………………………………………………………………………………………………
Any history of food allergies or intolerance in parents or siblings? …………………………………………………………………………
Were there any feeding issues with the parents as babies? .....................................................................................
Feeding History (from birth)
Initial feeding method, changes in feeding and reasons why e.g. stopped breastfeeding, started mixed feeding,
changes in formula brand or type ……………………….………………………………………………………………………………………………….
Current feed volumes and frequency per day………………………………………………………………………………………………………...
Age of weaning, types of solids introduced so far ………………………………………………………………………………………………....
Any poor feeding/ food refusal/ aversion ……………………………………………………………………………………………………….......
Bowels
Consistency (slimey, frothy, hard, soft, watery), colour, offensive smell …………………………………………………………………
Frequency …………………………………………………………………………………………………………………………...................................
Changes in bowel habits/ at what age/ does it coincide with anything e.g. introduction of formula or solids, or
following/ during a feed …………………………………………………………………………………………………………………………………………
Presence of mucus or blood …………………………………………………………………………………………………………………………….......
Presence of nappy rash, stool testing (pH < 5.5, reducing substances present)? ......................................................
Discomfort
Severity and type e.g. screaming, drawing up legs, abdominal distension/ pain……………………………………………………
………………………………………………………………………………………………………………………………………………………………………………
Time of day, how long for, is the baby able to sleep appropriately …………………………………………………………..............
What settles baby e.g. position (supine/ prone), alternative environments?........................................................
………………………………………………………………………………………………………………………………………………………………………………
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Updated September 2016
- 25 -
Sickness
When does the sickness occur?.............................................................................................................................
If associated with feeds, how soon after feed and after how much feed, how many times a day, how much vomit
and is it projectile?................................................................................................................................................
Does anything reduce the vomiting (e.g. position - laying on front, staying upright)? ……………………………………………
Any wretching, coughing or gurgling in throat during feeding? …………………………………………………………………...........
Breathing
Are they chesty, is there a cough, wheeze or nasal secretions/ blockages?...........................................................
………………………………………………………………………………………………………………………………………………………………………………
Skin
Rashes e.g. redness (erythema), urticaria, swelling (angio-oedema) and timing of onset of rashes following
food/drink? …………………………………………………………………………………………………………………………………………………………….
Dry skin/ eczema. Severity of eczema – do they need steroid creams/ wet wraps and if so, how often? Does the
skin bleed?.............................................................................................................................................
Weight/ growth and signs of malnutrition
Are they gaining weight and growing well?
Yes
No
………………………………………………………………………………………………………………………………………………………………………………
Are they active or unduly tired?
………………………………………………………………………………………………………………………………………………………………………………
Do they look pale or frequently suffer from illnesses?
………………………………………………………………………………………………………………………………………………………………………………
Treatments
What medications or other therapies have they tried so far and what has/ hasn’t worked?
………………………………………………………………………………………………………………………………………………………………………………
What medications are they currently on?
…………………………………………………………………………………………………………………………………
Have they been referred to anyone?....................................................................................................................
Name & base of Health Professional:
_________________ Tel no:
Signature:
Date:
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Updated September 2016
- 26 -
Appendix 2 - Checking food labels
European Union (EU) food labeling laws require that labels must clearly state whether cow’s milk,
in addition to other allergens such as soya, egg and wheat, is an ingredient in a food product.
These laws will also have to apply to unpackaged foods and when eating out in the EU from
December 2014. If you travel outside the EU, be aware that labelling laws are different and check
ingredients carefully. Foods sold loose eg. from a bakery, delicatessen or butcher; foods packed
for direct sale eg. sandwich bars, in-store bakeries, and some catering products will have to
provide allergen information, whether it’s on a chalk board, chart or provided verbally. You could
carry a ‘chef card’ to give to restaurant staff stating which allergens you need to avoid. These can
be downloaded from http://multimedia.food.gov.uk/multimedia/pdfs/chefcard.pdf
More
information
on
food
allergy
labeling
is
available
from
the
FSA:
http://multimedia.food.gov.uk/multimedia/pdfs/publication/allergy-leaflet.pdf
There are many ways in which cow’s milk can be labeled, so carefully check the ingredients list on
food items and avoid foods which contain:
Cow’s milk (fresh, UHT)
Butter milk, butter oil
Casein (curds), caseinates
Evaporated milk
Condensed milk
Calcium caseinate
Yogurt, fromage frais
Cheese
Sodium caseinate
Margarine
Butter, Ghee
Hydrolysed casein
Ice cream
Cream/ artificial cream
Hydrolysed whey protein
Milk powder
Skimmed milk powder
Whey, whey solids
Milk protein
Milk solids
Whey protein
Modified milk
Lactoglobulin
Lactoalbumin
Lactose - in most cases only needs to be avoided if your child has lactose intolerance or is thought
to have secondary lactose intolerance as part of a pattern of GI-related non-IgE mediated
symptoms
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Updated September 2016
- 27 -
By law you must be able to clearly identify that a product contains milk/ a milk derivative. For
example, if casein is listed, it should tell you in brackets afterwards that this is ‘from milk’.
Allergens will be highlighted in the ingredients list in bold, italics, underlined or highlighted. Only
if the product does not have an ingredients list will a statement be allowed.
Example of food label containing cow’s milk
Olive spread (margarine):
Ingredients: Vegetable oils [including olive oil (22%)], water, whey powder (milk), salt (1.3%),
stabiliser (sodium alginate), emulsifier (mono and diglycerides of fatty acids), lactic acid, natural
flavouring, vitamins A and D, colour (carotenes)
Allergy Advice: for allergens, see ingredients in bold.
This margarine is therefore not suitable for a cows’ milk free diet.
'May contain…'/’Made in a factory…’ labeling: Some labels say ‘may contain cow’s milk’ or ‘not
suitable for cow’s milk allergy’ as the manufacturer may not be able to ensure that the product
does not accidentally contain small amounts. Discuss with your dietitian whether you need to
avoid these foods.
Allergy Alerts: Sometimes foods have to be withdrawn or recalled if there is a risk to consumers
because the allergy labeling is missing or incorrect or if there is any other food allergy risk. These
alerts are available from the Food Standards Agency website. It is also possible to subscribe to a
free email or SMS text message alert system to receive automatic messages whenever such
Allergy Alerts are issued. To subscribe go to:
www.food.gov.uk/safereating/allergyintol/alerts.
Introduction of solids in a child at risk of allergy.
For guidance on starting weaning see:
http://www.allergyuk.org/advice-for-parents-with-a-new-baby/weaning-your-baby-on-to-solids
You can also obtain first line information on cow’s milk free foods from the British Dietetic
Association: https://www.bda.uk.com/foodfacts/milkallergy
Dr Lisa Waddell
Ratified by NAPC January 2015
Review date: September 2018
Produced February 2011
Updated September 2016
- 28 -