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A GUIDE FOR PRESCRIBING SPECIALIST FORMULAS IN PRIMARY CARE
FOR THE DIAGNOSIS, TREATMENT AND MANAGEMENT OF COWS’ MILK PROTEIN
ALLERGY
Authors: Chris Smith Paediatric Dietician Royal Alexandra Children’s Hospital, Dr Assad
Butt Consultant Paediatric Gastroenterologist
REFERRALS TO RACH
All children requiring longer term elimination diets e.g. > 6 weeks should be referred to paediatric Dietitians.
Children with severe symptoms or anaphylaxis should be referred to speciality allergy and gastroenterology services.
BACKROUND
Making the right choice of formula for infants presenting with cows’ milk protein allergy (CMPA) is important in both
the infants’ best interests and the financial implication on the NHS. The incidence of CMP (Cows ‘milk protein) allergy
appears to peak in the first year of life with a prevalence of around 2% to 7% in the infant population. Recognition of
the condition has been greatly increased in the UK in part due to several well established guidelines on its
identification and management.
ASSESSMENT AND DIAGNOSIS
Clear and established algorithms guide the management pathways. Full clinical guidelines can be found at the
following:
MAP GUIDELINES
http://www.ctajournal.com/content/3/1/23
Diagnosis and management of non-IgE-mediated cow’s milk allergy in infancy - a UK primary care practical guide. 2013
NICE
http://guidance.nice.org.uk/CG116
In most cases with suspected CMPA the diagnosis needs to be confirmed or excluded by an allergen elimination and
challenge procedure.
Royal Alexandra Children’s Hospital Algorithm for the
Diagnosis and Management of Cows’ Milk Protein Allergy
SUSPICION OF MILD TO MODERATE CMPA
One or more of the following symptoms:

Gastrointestinal: frequent regurgitation, vomiting, diarrhoea, constipation (without perianal rash), blood in stool, iron deficiency anaemia

Dermatological: atopic dermatitis

General: persistent distress or colic (> 3 hours per day walling/irritable) at least 3 days/week over a period of > 3 weeks

Others: (rare)
ELIMINATION DIET
BREASTFEEDING
Elimination diet in mother
Elimination diet in mother – no CMP plus Ca-supplement
FORMULA FED-INFANTS
Therapeutic Extensive Hydrolysed Formula (eHF)
2 to 4 weeks elimination
IMPROVEMENT
Challenge
If acute and objective symptoms of skin (acute urticaria,
angioedema), respiratory tract (stridor, wheezing) or
systemic reactions (anaphylaxis) occur immediately, or
up to 2 hours after a clear history of ingesting dairy
products, then CMP should be strictly excluded. In this
situation, the oral challenge test can be omitted.
NO CMPA SYMPTOMS
Resume CMP in diet
and monitor
NO IMPROVEMENT
An allergic reaction to the remaining peptides in the eHF
must be considered, particularly in infants with
sensitisation against multiple foods.
Amino Acid Formula (AAF) Minimal for 2-4 weeks
CMPA SYMPTOMS
Maintain CMP elimination diet until 9
to 12 months of age, but for at least
6 months. Refer to dietician for
advice on management.
IMPROVEMENT
Refer to dietician
for advice on
management.
NO IMPROVEMENT
Unlikely to be CMPA consider
differential diagnosis and
refer to specialist
SUSPICION OF SEVERE CMPA
One or more of the following symptoms:

Gastrointestinal: Failure to thrive due to chronic diarrhoea, and/or regurgitation/vomiting and or refusal to feed; iron deficiency
anaemia due to occult or macroscopic blood loss; protein losing enteropathy (hypoalbuminaemia); endoscopic/histologically
confirmer enteropathy or severe allergic colitis

Dermatological: Exudative or severe atopic dermatitis with hypoalbuminaemia-anaemia or failure to thrive or iron deficiency anaemia

Respiratory: Acute layngoedema or bronchial obstruction with difficulty in breathing

Systemic reaction (anaphylactic shock – needs immediate referral to hospital for management)
ELIMINATION DIET
Amino Acid Formula (AAF) Minimal for 2-4 weeks
REFERRAL TO
PAEDIATRIC SPECIALIST
TREATMENT + PRESCRIPTIONS
HIG
FIRST LINE
EXTENSIVELY HYDROLYSED
FORMULAE (lactose free)
SECOND LINE
EXTENSIVELY HYDROLYSED
FORMULAE (containing
lactose) *
EXTENSIVELY HYDROLYSED
FORMULAE WITH MEDIUM
CHAIN TRIGLYCERIDES
TO BE STARTED IN
SECONDARY CARE.
AMINO ACID FORMULAE
NORMALLY (1)
TO BE STARTED IN
SECONDARY CARE.
Nutramigen Lipil 1
Birth to 6 months
(Mead Johnson)
Nutramigen Lipil 2 *
6 months onwards
(Mead Johnson)
* Higher calcium content in this formula likely to be required due to
restriction of dairy foods in weaning diet. Requires dietetic
assessment.
First line for patient with severe CMPA is amino acid formula (See
AMINO ACID box below)
NOTE- Alternative extensively hydrolysed formulas available nationally
but not on local formulary are:
Similac Alimentum (Abbott), Althera (SMA)
Pepti 1
Birth to 6 months
(Cow and Gate)
Pepti 2
6 months to 1 year
(Cow and Gate)
*These formulas may be tried if infant is not tolerating first line
products because of refusal associated with taste.
Pepti Junior ®
(Cow and Gate)
Birth to 2 years or birth to 1 year if
can then tolerate over the counter
suitable milk alternatives
®
Pregestimil Lipil
Birth to 2 years or birth to 1 year if
(Mead Johnson)
can then tolerate over the counter
suitable milk alternatives
These formulas are used where CMPA is accompanied by
malabsorption.
Neocate LCP
(Nutricia)
Neocate Active®
(Nutricia) (2)
Neocate Advance®
(Nutricia) (3)
Birth to 1 year
1 year onwards
1 year onwards
1. If a patient presents with clear anaphylactic reaction to cow’s milk
these formula should be commenced in primary care, with immediate
onward referral to secondary or specialist care.
2. Neocate Active® is a high calorie formula and will not be required
automatically by all infants over 1 year. It is not suitable as a sole
source of nutrition. Seek dietetic advice.
3. Neocate Advance® is a sole source of nutrition for patients with
CMPA aged 1-10 years. It is a high calorie product and will not be
required automatically by all patients over 1 year. Seek dietetic advice.
4. If formula top-ups are needed for a child who is otherwise breastfed
(mother on a milk free diet) AAF will be required.
NOTE- Alternative amino acid formulas available nationally but not on
local formulary are:
Nutrmigen AA (Mead Johnson), Alfamino (SMA)
Non–Specialist Drugs
Specialist Initiation WITHOUT
Shared Care Drugs
Specialist Initiation WITH
Shared Care Drugs
Specialist ONLY Drugs
RGY FORMULA
IRST-LINE
GUIDE TO PRESCRITION VOLUMES
Age of child
Number of tins for 28 days
Under 6 months
13 x 400g tins or 6 x 900g tins
6-12 months
7-13 x 400g tins or 3-6 x 900g tins
Over 12 months
7 x 400g tins or 3 x 900g tins
DURATION OF ELIMINATION DIET
The duration of a diagnostic elimination diet (either mother restriction in a breast fed case or use of an extensively
hydrolysed in a bottle fed) depends on manifestation and should be kept as short as possible, but long enough to
judge whether clinical symptoms resolve or not or become stable. This ranges from 3 – 5 days in children with
immediate clinical reactions (e.g. angioedema, vomiting or exacerbation of eczema within 2 hours) to 1 – 2 weeks in
children with delayed clinical reactions (e.g. exacerbation of eczema, rectal bleeding). In patients with
gastrointestinal reactions (e.g. chronic diarrhoea, growth faltering) it may take 2 to 4 weeks on a CMP free diet to
judge on the response.
If there is no improvement in symptoms within these timelines, CMPA is unlikely.
FOLLOW UP AND RESOLUTION
Patients should be re-evaluated every 6 – 12 months to assess whether they have developed tolerance to CMP. This
is achieved in >75% of children by three years and >90% by six years of age.
LACTOSE AND CMPA
Adverse reactions to lactose in CMPA are not supported in the literature and complete avoidance of lactose in CMPA
is not warranted. These formulae may also be more palatable for infants over 6 months.
It is however possible for secondary lactose intolerance to co-exist in infants who have enteropathy with diarrhoea
and therefore a lactose-free eHF will be required initially in these cases.
SECONDARY LACTOSE INTOLERANCE
(Adapted from PrescQipp)
Symptoms and diagnosis
• Lactose intolerance is defined as a non-immune mediated adverse reaction to food i.e. it is not due to allergy but a
lack of the enzyme lactase.
• Usually occurs following an infectious gastrointestinal illness but may be present alongside newly or undiagnosed
coeliac disease.
• Symptoms include abdominal bloating, increased (explosive) wind, loose green stools.
• Lactose intolerance should be suspected in infants who have had any of the above symptoms that persist for more
than 2 weeks.
• Resolution of symptoms within 48 hours of withdrawal of lactose from the diet confirms diagnosis.
Onward referral
• If symptoms do not resolve when standard formula and/or milk products are reintroduced to the diet, refer to
secondary or specialist care.
• Refer to the paediatric dietitian if the child is weaned and a milk free diet is required.
Treatment
• Treat with low lactose/lactose free formula not a hypoallergenic formula) Appropriate formulas include Enfamil OLac (Mead Johnson) or SMA Lactofree. These are a similar price to standard formulas and parents should be
encouraged to buy them
•Treat for 4-8 weeks to allow symptoms to resolve. Rarely symptoms may last up to 3 months
• In infants who have been weaned, low lactose/lactose free formula should be used in conjunction with a milk free
diet.
• Standard formula and/or milk products should then be slowly reintroduced to the diet.
• In children over 1 year who previously tolerated cow’s milk, do not prescribe low lactose/lactose free formulae.
Suggest use of lactose free full fat cow’s milk, yoghurt and other dairy products which can be purchased from
supermarkets (Lactofree® brand).
REFERENCES
1) Venter et al. Diagnosis and management of non-IgE-mediated cow’s milk allergy in infancy - a UK primary care practical guide Clinical and Translational Allergy
2013 3:23
2) Koletzko B, et al. Diagnostic Approach and Management of Cow’s-Milk Protein Allergy in Infants and Children: ESPGHAN GI Committee Practical Guidelines.
Journal of Paediatric Gastroenterology and Nutrition. Volume 55, Number 2, August 2012
3)Fiocchi A et al. World Allergy organization (WAO) diagnosis and rationale for action against Cow's milk allergy (DRACMA) guidelines. World Allergy Organ J
2010, 3(4):57-161.
4) Sladkevicius E et al. Resource implications and budget impact of managing cow milk allergy in the UK. J Med Econ 2010, 13(1):119-128
5)Allen KJ et al. Management of cow's milk protein allergy in infants and young children: an expert panel perspective. J Paediatr Child Health 2009, 45(9):481-486.
Prepared Aug 2014
Reviewed Aug 2015
Date for review Aug 2016