Cow’s Milk Protein Allergy

Whilst these guidelines advise on the appropriate choice of specialist infant formula for cow’s milk protein allergy (CMPA), breast milk remains the optimal choice for infants. This should be promoted and encouraged where it is clinically safe to do so.

The guideline details, the diagnosis and management of CMPA (also available as a visual summary flowchart for CMPA).

Symptoms of CMPA

Refer to NICE guideline CG116 ‘Food Allergy in Children and Young People’ and Milk Allergy in Primary Care (iMAP) for full details on symptoms and taking an allergy focused clinical history. The immune response to cows’ milk protein can be classified as an IgE-mediated allergy or a non-IgE-mediated allergy.

Symptoms commonly are persistent and affect multiple organ systems (e.g. skin, gastrointestinal, respiratory or anaphylaxis). Family history of atopic disease also makes diagnosis more likely.

In the UK, CMPA affects only 2 to 3% of infants. It is important to consider other causes and treatment for isolated symptoms (such as rashes, constipation, eczema, reflux) to avoid overdiagnosis.  

Management of suspected IgE mediated CMPA

ALL infants with suspected IgE mediated CMPA should be referred to paediatric allergy team without delay following recommendation of an appropriate hypoallergenic formula. 

  • For mild to moderate symptoms an Extensively Hydrolysed Formula (EHF) should be recommended as first line. For severe symptoms consider an Amino Acid Formula. See the ‘Choice of Formula’ section below section below for details on formula to prescribe.
  • Advise strict avoidance of cow’s milk protein.
  • In secondary care a cow’s milk specific IgE antibody test can be used. A positive result combined with positive clinical history will confirm diagnosis. If the result is negative, treat in line with non-IgE mediated CMPA or consider an alternative diagnosis.

Management of Suspected Non-IgE-mediated CMPA

For all suspected non-IgE mediated CMPA, consider referral to a paediatric dietitian. GP to continue management until the infant is assessed by a dietitian; this includes initiating a prescription for a hypoallergenic formula where appropriate.

Exclusively breast-fed infants

  • Breast milk is the optimum choice for infants with CMPA. Exclusive breastfeeding is recommended for 26 weeks (6 months). Mothers should be actively encouraged to continue breastfeeding. Consider providing iMAP patient information leaflet on supporting breastfeeding.
  • Trial strict exclusion of cow’s milk from maternal diet. Information on a cow’s milk free diet and appropriate cow’s milk substitutes are available from the British Dietetic Association and iMAP.
  • Breastfeeding mothers on a cow’s milk-free diet should take a daily supplement containing 10 micrograms (400 units) of Vitamin D. Calcium 1000 milligram supplement may also be needed if unable to meet requirements through diet alone.
  • If formula top-ups are required or if mothers are unable or do not wish to continue breastfeeding, an Extensively Hydrolysed Formula (EHF) can be prescribed as first line.
  • For infants who are taking solids, a cow’s milk free diet should also be advised.
  • Reintroduction of cow’s milk protein is essential to confirm or exclude a diagnosis of mild to moderate non-IgE mediated CMPA. After 2 to 4 weeks, re-introduce cow’s milk protein back into the maternal diet over a 1-week period:
    • If symptoms do not return then the diagnosis is not CMPA
    • If symptoms return the diagnosis is confirmed and advice should be given to return to a strict elimination of cow’s milk protein for mother / infant until the infant is 9 to12 months old and for at least 6 months.

Formula Fed Infants

  • Trial an Extensively Hydrolysed Formula (EHF) as the first line treatment. At least 90% of infants with CMPA should respond to an EHF. Refer to the ‘Choice of Formula’ section below. Amino Acid Formulas (AAF) for CMPA should not be prescribed as first line unless there is evidence of severe allergy, anaphylaxis, or a trail of two EHF does not resolve symptoms.
  • For infants who are taking solids, a cow’s milk free diet should also be advised.
  • Reintroduction of cow’s milk protein is essential toconfirm or exclude a diagnosis of mild to moderate non-IgE mediated CMPA. After 2 to 4 weeks, reintroduce cow’s milk formula:
    • Refer to the iMAP Home Reintroduction protocol to provide parents with structured formula reintroduction information.
    • If symptoms do not return then the diagnosis is not CMPA
    • If symptoms return the diagnosis is confirmed and advice should be given to return to a strict elimination of cow’s milk protein until the infant is 9 to 12 months old and for at least 6 months.

Check if tolerance has been acquired

Once the infant is 9 to12 months old and a cow’s milk free diet has been followed for at least 6 months, the milk ladder can be used to check if tolerance has been acquired. The paediatric dietitian can support with this and it should only be used for those with mild to moderate non-IgE CMPA.

Considerations when choosing a hypoallergenic formula

  • EHF and AAF have an unpleasant taste and smell. Consider age of the infant when initially prescribing the formula. An EHF containing lactose will likely be more palatable for infants who have started weaning.
  • Unless there is anaphylaxis, advice can be provided on introducing the EHF or AAF gradually alongside usual formula. It may help to gradually introduce the formula over several days, mixing it with their usual milk in increasing quantities until the taste is accepted.
  • If symptoms are still persistent or only partially resolved, two different EHF can be trialled before considering a prescription for AAF. Ideally both a casein and whey-based EHF should be trialled. See ‘Choice of Formula’ section below for details.

Onward Referral

Non-IgE CMPA can be managed in primary care:

  • Referral to a paediatric dietitian should be made prior to weaning for all infants who will require a cow’s milk free diet. Milk-free advice for breastfeeding mothers can be provided via iMAP guidelines and referral to paediatric dietitian can be made once diagnosis is confirmed.

Refer infant to paediatric allergy team if any of the following apply:

  • Suspected IgE-mediated CMPA (refer without delay following recommendation of an appropriate cow’s milk substitute)
  • Faltering growth with one or more GI symptoms
  • Acute systemic reactions or severe delayed reactions
  • Significant atopic eczema where multiple or cross-reactive food allergies are suspected by the parent or carer
  • Possible multiple food allergies
  • Persisting parental suspicion of food allergy despite a lack of supporting history (especially where symptoms are difficult or perplexing)

Follow the referral processes for your local SWL Borough.

Choice of Formula

A summary of the choice of formula is listed below.

First Line Extensively Hydrolysed Formula (EHF)

SMA Althera®

Birth to 12 months. Whey based. Contains lactose. Suitable for halal and vegetarian diets. Not suitable for kosher or vegan* diets.

Aptamil® Pepti 1

Birth to 6 months. Whey based. Contains lactose. Suitable for kosher diets. Not suitable for halal, vegetarian or vegan diets.

Aptamil® Pepti 2

6 months to 12 months. Whey based. Contains lactose. Suitable for kosher diets. Not suitable for halal, vegetarian or vegan diets.

Second Line Extensively Hydrolysed Formula (EHF)

To be prescribed on recommendation of a dietitian, or if first line EHF not suitable or not tolerated.

Nutramigen 1 with LGG®

Birth to 6 months. Casein based. Lactose free. Contains probiotics. Not suitable for premature or immunocompromised infants. Not suitable for halal, kosher, vegetarian or vegan diets.

Nutramigen 2 with LGG®

6 months to 12 months or until able to tolerate over the counter products. Casein based. Lactose free. Contains probiotics. Not suitable for premature or immunocompromised infants. Not suitable for halal, kosher, vegetarian or vegan diets.

Other Extensively Hydrolysed Formulas:

Not to be routinely initiated in primary care unless recommended by a dietitian.

Nutramigen 3 with LGG®

Children from 1 year or until able to tolerate over the counter products. Casein based. Lactose free. Contains probiotics. Not suitable for premature or immunocompromised infants. Not suitable for halal, kosher, vegetarian or vegan diets.

Aptamil® Pepti Syneo

Birth to 12 months or until able to tolerate over the counter products. Whey based. Contain lactose. Contains probiotics and prebiotics. Not suitable for premature or immunocompromised infants. Suitable for kosher diets. Not suitable for halal, vegetarian or vegan diets.

Extensively Hydrolysed Formula with Medium Chain Triglycerides

Products with 50% or more medium chain triglycerides, for use when CMPA is accompanied by malabsorption. Not to be routinely initiated in primary care unless recommended by a dietitian.

Aptamil® Pepti-Junior

Birth to 12 months or until able to tolerate over the counter products. Not suitable for halal, kosher, vegetarian or vegan diets.

Preferred Amino Acid Formula (AAF)

Not to be routinely initiated in primary care. Do not prescribe unless there is evidence of severe (anaphylactic) allergy or trial of two EHF does not resolve symptoms.

SMA Alfamino®

Birth to 12 months or until able to tolerate over the counter products. Suitable for halal diets. Not suitable for kosher**, vegetarian* or vegan* diets.

Neocate® LCP

Birth to 12 months or until able to tolerate over the counter products. Suitable for halal, kosher and vegetarian diets. Not suitable for vegan diets.

Nutramigen Puramino®

Birth to 12 months or until able to tolerate over the counter products. Suitable for halal and kosher diets. Not suitable for vegetarian or vegan diets.

Other Amino Acid Formula (AAF)

Not to be routinely initiated in primary care unless recommended by a dietitian.

Neocate® Junior

Children 1 year onwards or until able to tolerate over the counter products. This is a high calorie formula and will not be required automatically for infants over 1 year. Suitable for halal, kosher and vegetarian diets. Not suitable for vegan diets.

Neocate® Spoon

6 months onwards. May be recommended by a dietitian for cases of multiple food allergy. Not suitable as a sole source of nutrition. Suitable for halal, kosher and vegetarian diets. Not suitable for vegan diets.

Neocate® Syneo

Birth to 12 months or until able to tolerate over the counter products. Contains probiotics and prebiotics. Not suitable for premature or immunocompromised infants.

Suitable for halal, kosher and vegetarian diets. Not suitable for vegan diets.

Other Infant Formula and Milks (to be purchased Over the Counter from pharmacies or supermarkets)

Soya Formula

Such as SMA® Soya Infant Formula – Should NOT be used for infants under 6 months of age due to high phyto-oestrogen content and risk of cross reactivity. If Soya formula is used for infants over 6 months of age, parents should purchase this over the counter. Calcium fortified soya milk may be suitable from 1 year of age.

Rice Milk

NOT suitable for infants and children under 5 years of age due to its arsenic content.

Partially Hydrolysed Formula

Such as Aptamil® Comfort or Cow & Gate® Comfort – NOT suitable for infants with CMPA.

Goat or Sheep Milk

NOT suitable for infants with CMPA due to risk of cross reactivity.

Lactose-free Milk / Formula

NOT suitable for infants with CMPA as it still contains whole cow’s milk proteins.

Calcium fortified Soya, Oat, Pea, Coconut, Nut Milks

Suitable for use in food preparation (e.g. in porridge) from 6 months of age. May be suitable as the main milk drink from 1 year of age. The paediatric dietitian will be able to advise on suitable plant-based milks to drink from 1 year of age, or see SWL ‘Dairy Free Products Guide’

*The Vitamin D in this product is derived from sheeps’ wool

**Not kosher certified, however the ingredients used are not contra-indicated for patients following a Kosher diet

Review and discontinuation of prescriptions

  • Prescriptions should be reviewed and discontinued when the child reaches 12 months of age. For some children a few tins may be required to allow for a transition period onto supermarket calcium fortified plant-based milk (see SWL ‘Dairy Free Products Guide’). This should be a one-off prescription and should not exceed 5 tins.
  • Refer to the most recent correspondence from the paediatric dietitian when reviewing prescriptions and liaise with the paediatric dietitian if required.
  • Review prescriptions regularly to check that the formula prescribed is in line with dietetic advice; appropriate for the child’s age and is the correct volume for age.
  • Initially prescribe only 2 tins until compliance is established unless samples have already been trialled and tolerated. Following this a 1 month acute prescription can be issued.
  • Review the need for the prescription if you can answer ‘yes’ to any of the following questions:
    • Is the child over 12 months of age?
    • Is the infant/child prescribed more than the suggested quantities of formula according to their age?
    • Is the infant eating any of the following foods; cow’s milk, cheese, yogurt, ice-cream, custard, chocolate, cakes, cream, butter, margarine, ghee? If yes this may be an indication CMPA has resolved.
  • Children with multiple or severe allergies may require prescriptions up to and beyond 2 years of age if recommended by the paediatric dietitian due to an overly restricted diet. This should be documented in the patient’s consultation notes at the GP practice.
  • Ensure child’s growth is monitored and recorded. Review treatment if child is not thriving.

Reference and resources