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Dr Lisa Waddell Produced February 2011 Ratified by NAPC January 2015 Updated May 2017 Review date: September 2018 - 1 - 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 toolbox 1 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.

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Page 1: GUIDANCE ON THE DIAGNOSIS AND MANAGEMENT OF · GUIDANCE ON THE DIAGNOSIS AND MANAGEMENT OF ... if and when the child needs to be referred to secondary or specialist dietetic care

Dr Lisa Waddell Produced February 2011 Ratified by NAPC January 2015 Updated May 2017 Review date: September 2018

- 1 -

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.

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Dr Lisa Waddell Produced February 2011 Ratified by NAPC January 2015 Updated May 2017 Review date: September 2018

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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

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Dr Lisa Waddell Produced February 2011 Ratified by NAPC January 2015 Updated May 2017 Review date: September 2018

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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.

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Dr Lisa Waddell Produced February 2011 Ratified by NAPC January 2015 Updated May 2017 Review date: September 2018

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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 re-

challenge occurring at 1 year of age, as outlined under treatment (p15-17).

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Dr Lisa Waddell Produced February 2011 Ratified by NAPC January 2015 Updated May 2017 Review date: September 2018

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Table 1 Symptoms of food allergy5

IgE- mediated Non-IgE-mediated

The Skin

Pruritus

Erythema

Acute urticaria (localised/ generalised)

Acute angioedema (commonly lips, face & eyes)

Acute flaring of atopic eczema

Pruritus

Erythema

Unexplained skin rashes

Moderate to severe atopic eczema

The Gastrointestinal system (GI)

Angioedema of lips, tongue & palate

Oral pruritus

Nausea

Vomiting

Colicky abdominal pain

Diarrhoea

Gastro-oesophageal reflux disease

Vomiting

Loose or frequent stools

Blood and/or mucus in stools

Abdominal distension and pain

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,

sneezing, rhinorrhoea or congestion (with/ without

conjunctivitis)

Upper and lower ‘Catarrhal’ airway symptoms

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

Other

Signs or symptoms of anaphylaxis or other systemic

allergic reactions

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Dr Lisa Waddell Produced February 2011 Ratified by NAPC January 2015 Updated May 2017 Review date: September 2018

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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 Recommended product

Mild/

Moderate

For the majority of gastrointestinal and atopic symptoms of cow’s milk allergy

Extensively Hydrolysed Infant Formula (EHF):

1st line – casein based, lactose free

2nd line – whey based with lactose

1st Line: Nutramigen 1 with LGG or Nutramigen 2 with LGG (MJ Nutrition) (> 6 months age) (£10.87 for 400g tin)

2nd Line: SMA Althera (£10.68 for 450g tin)

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

Amino Acid Infant Formula (AAF)

1st line: Neocate LCP (£28.30 for 400g tin) or Neocate Junior (Nutricia) [> 12 months age) (£28.30 for 400g tin) (Flavours; unflavoured, vanilla)]

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.

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Dr Lisa Waddell Produced February 2011 Ratified by NAPC January 2015 Updated May 2017 Review date: September 2018

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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

HAF

< 10 weeks

Day 1: 50:50 mix of HAF with existing formula Day 2: All HAF

3 3

10-20 weeks

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.

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Dr Lisa Waddell Produced February 2011 Ratified by NAPC January 2015 Updated May 2017 Review date: September 2018

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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

2

3

4

5+

1tsp normal formula

1floz normal formula in one morning bottle only

2floz normal formula in one morning bottle only

1floz normal formula/ bottle/ day

Increase in 1floz increments/ bottle/ day (see table 3)

1 tsp yogurt in morning

2 tsp yogurt in morning

4 tsp yogurt in morning

½ pot of yogurt during day

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.

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Dr Lisa Waddell Produced February 2011 Ratified by NAPC January 2015 Updated May 2017 Review date: September 2018

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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 Junior (Nutricia) [> 12 months

age) (£28.30 for 400g tin) (Flavours; unflavoured, vanilla)]

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Dr Lisa Waddell Produced February 2011 Ratified by NAPC January 2015 Updated May 2017 Review date: September 2018

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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.

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.

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 8-12 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

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Dr Lisa Waddell Produced February 2011 Ratified by NAPC January 2015 Updated May 2017 Review date: September 2018

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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 1-12 years – Nottinghamshire Healthcare NHS Foundation Trust

Phlebotomy Service

GP’s to print blood form from Sunquest ICE and give to patient with

prescription for anaesthetic cream if appropriate

Patient/ GP to contact single point of access (SPA) on Tel 0300 123 3387 to

book an appropriate appointment. Choice of location provided

Children 13 years+ – Parents to contact Clinical Assessment Service (CAS):

Tel 0115 883 3000 who will pass on details to chosen provider

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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)

50 – 100 (Grade 5)

>100 (Grade 6)

Very high levels can result from a high total IgE, but IgE

mediated CMA nevertheless highly likely

*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.

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Dr Lisa Waddell Produced February 2011 Ratified by NAPC January 2015 Updated May 2017 Review date: September 2018

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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.

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Dr Lisa Waddell Produced February 2011 Ratified by NAPC January 2015 Updated May 2017 Review date: September 2018

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Table 6 Referral to dietetic services across Nottinghamshire

Nottinghamshire CCG Severity of cow’s milk allergy Dietetic provider

Nottingham City 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

Nottingham CityCare Partnership, Community Nutrition and Dietetic Dept

_____________

NUH paediatrician and dietitian

South County CCGs (Rushcliffe, NE, NW)

Mild/ moderate non-IgE mediated CMA

_____________

All forms of IgE mediated CMA

Severe CMA and multiple food allergies

Nottingham Healthcare NHS Foundation Trust, Community Nutrition and Dietetic Dept

_____________ NUH paediatrician and dietitian

Mid Notts CCGs Mild/ moderate non-IgE mediated CMA

_____________

All forms of IgE mediated CMA

Severe CMA and multiple food allergies

Nottingham Healthcare NHS Foundation Trust, Community Nutrition and Dietetic Dept

_____________ Sherwood Forest Hospitals paediatrician and dietitian

North Notts CCGs All forms of non-IgE mediated CMA

All forms of IgE mediated CMA

Bassetlaw Hospital paediatrician and dietitian

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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 diet10. In IgE mediated infants, re-

challenging 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

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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 immediate-

type reactions indicative of IgE mediated allergy should also be re-challenged in hospital, unless

previously positive specific IgE blood tests are now negative.

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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 adolescence12. The child should be given

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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

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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 phyto-

oestrogen 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

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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

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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, Nottingham Healthcare NHS Foundation Trust), Katie Conchie (Dietitian, Sherwood Forest Hospitals), 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.

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Food allergy care pathway for children under Nottingham City CCG

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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?........................................................

………………………………………………………………………………………………………………………………………………………………………………

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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:

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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

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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:

https://www.allergyuk.org/information-and-advice/conditions-and-symptoms/42-childhood-food-

allergy - download ‘Weaning your baby onto solids’ fact sheet.

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

Try downloading the Foodmaestro app–a free from product finder: http://www.foodmaestro.me/