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Guidelines for the use of infant formulas to treat cows milk protein allergy: an Australian consensus panel opinion

Andrew S Kemp, David J Hill, Katrina J Allen, Kym Anderson, Geoffrey P Davidson, Andrew S Day, Ralph G Heine, Jane E Peake, Susan L Prescott, Albert W Shugg and John K Sinn
Med J Aust 2008; 188 (2): 109-112. || doi: 10.5694/j.1326-5377.2008.tb01534.x
Published online: 21 January 2008

Various infant formulas — such as soy, extensively hydrolysed and amino acid-based formula — that can be used to treat cows milk protein allergy are available in Australia. An analysis of Australian formula-prescribing practices indicated that they did not appear to be in line with authoritative statements and position papers or the guidelines of the Australian Pharmaceutical Benefits Advisory Committee (PBAC).1

In 2000, the Committee on Nutrition of the American Academy of Pediatrics stated that soy formula was a suitable option for treating infants with cows milk protein allergy.2 In April 2006, the Committee on Nutrition of the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) recommended that soy protein formulas should not be used in infants with cows milk protein allergy during the first 6 months of life, because few infants had been studied, and the reported rate of adverse reactions to soy protein was higher in infants under 6 months of age. This committee also recommended that, when soy formula is used to treat cows milk protein allergy in infants over 6 months of age, tolerance to soy formula be established by clinical challenge.3

The PBAC guidelines once restricted the use of extensively hydrolysed formula to infants with combined intolerance to cows milk protein and soy protein. It also restricted the use of amino acid formula to infants with combined intolerance to cows milk protein, soy protein and extensively hydrolysed formula. In November 2006, the PBAC accepted the advice of its Nutritional Products Working Party to ease the restrictions: the requirement to demonstrate intolerance to soy protein before treating infants with these products was removed.

In 2007, European proposals for treating cows milk protein allergy in formula-fed infants with extensively hydrolysed formula and amino acid formula were outlined in an algorithm.4

Consensus on the use of formulas

Three different types of formula (soy, extensively hydrolysed and amino acid) may be appropriate treatment in particular circumstances (Box 1). Some preparations are not recommended for treating cows milk protein allergy. The panel considers that there is no place for partially hydrolysed (known as HA) formulas nor other mammalian milks (such as goats milk)7 in treating cows milk protein allergy. The consensus recommendations for using infant formulas to treat allergy syndromes are shown in Box 2. Breastfeeding may be continued, and recommendations are provided for eliminating maternal intake of cows milk protein.

The panel believes the information provided is a guideline for most cases. However, in severely affected infants or if the diagnosis is uncertain, it may be appropriate to start treatment with an extensively hydrolysed or amino acid-based formula which is not in accordance with this consensus.8 Such a case should be managed by a paediatrician with particular expertise in these disorders.

Cows milk protein allergy syndromes

The syndromes are classified as reactions which develop over minutes, hours or days. The recommendations include advice about the necessity for mothers to eliminate dietary intake of cows milk protein while breastfeeding. In some situations, failure to thrive affects the choice of formula. Recommendations provide for an alternative formula if treatment with the initial formula is not successful.

Gastrointestinal syndromes

Infants with cows milk protein allergy may present with vomiting, chronic diarrhoea, malabsorption and failure to thrive. Most of the syndromes are not IgE associated and have other pathogenic immune mechanisms. Cows milk protein allergy is the most commonly identified food allergen sensitivity; however, in some cases, hypersensitivity to multiple food proteins is involved. Gastrointestinal biopsy may be required to define the disorder.

2 Formula feeding in syndromes associated with cows milk protein allergy*

Syndrome

Onset of reaction

Maternal elimination of CMP if breastfeeding?

Choice of formula


NHMRC level of evidence

Consensus panel agreement§

First

Second (if first not tolerated)

Third (if second not tolerated)


Immediate reaction

Immediate food allergy

< 1 h

Yes

eHF (< 6 months)

AAF

II

11/11

Soy (> 6 months)

eHF

AAF


Anaphylaxis

< 1 h

Yes

AAF (followed by urgent consultation with paediatric allergist)

IV

11/11


Food protein-induced enterocolitis syndrome

1–3 h

No

eHF

AAF

IV

10/11


Delayed reaction


Atopic eczema

Hours to days

Yes

eHF (< 6 months or > 6 months with FTT)

AAF

IV

11/11

Soy (> 6 months, no FTT)

eHF

AAF


Gastrointestinal syndromes, GORD, allergic eosinophilic gastroenteritis, food protein-induced enteropathy, constipation, severe irritability (colic)

Hours to days

Yes

eHF (< 6 months or > 6 months with FTT)

AAF

I (severe irritability), III (GORD), IV (others)

11/11

Soy (> 6 months, no FTT)

eHF

AAF


Food protein-induced proctocolitis

11/11

Formula-fed

> 24 h

eHF

AAF

IV

Breastfed

> 24 h

Yes


Eosinophilic oesophagitis in infants

Days to weeks

Yes

AAF

IV

11/11


CMP = cows milk protein. NHMRC = National Health and Medical Research Council. eHF = extensively hydrolysed formula. AAF = amino acid formula.
FTT = failure to thrive. GORD = gastro-oesophageal reflux disease. — = no further alternative choice.
* If restriction of multiple or common foods is indicated, advice from a dietitian on implementation may be required.
Complementary to breastfeeding or exclusive formula feeding.
NHMRC levels of evidence for intervention studies: I = systematic review of level II studies; II = randomised controlled trial; III = non-randomised experimental trial; IV = case series with either post-test or pretest–post-test outcomes.
§ Number of panel members in agreement with decision. May also need maternal elimination of other foods.

  • Andrew S Kemp1
  • David J Hill2
  • Katrina J Allen3
  • Kym Anderson4
  • Geoffrey P Davidson5
  • Andrew S Day6
  • Ralph G Heine3,7
  • Jane E Peake8
  • Susan L Prescott9
  • Albert W Shugg10
  • John K Sinn11

  • 1 Department of Allergy and Immunology, Children’s Hospital at Westmead, Sydney, NSW.
  • 2 Murdoch Childrens Research Institute, Royal Children’s Hospital, Melbourne, VIC.
  • 3 Department of Allergy and Clinical Immunology, Royal Children’s Hospital, Melbourne, VIC.
  • 4 Alice Springs Hospital, Alice Springs, NT.
  • 5 Department of Gastroenterology, Women’s and Children’s Hospital, Adelaide, SA.
  • 6 Department of Gastroenterology, Sydney Children’s Hospital, Sydney, NSW.
  • 7 Department of Gastroenterology and Clinical Nutrition, Royal Children’s Hospital, Melbourne, VIC.
  • 8 Department of Paediatrics and Child Health, University of Queensland, Royal Children’s Hospital, Brisbane, QLD.
  • 9 School of Paediatrics and Child Health, University of Western Australia, Princess Margaret Hospital, Perth, WA.
  • 10 University of Tasmania Rural Clinical School, Burnie, TAS.
  • 11 Department of Neonatology, Royal North Shore Hospital, Sydney, NSW.


Correspondence: AndrewK5@chw.edu.au

Acknowledgements: 

The panel gratefully acknowledges the support of SHS/Nutricia, which funded the teleconferences and face-to-face meetings for the preparation of this consensus. None of the panel members received any remuneration for their participation.

Competing interests:

Andrew Kemp has spoken at a clinical update sponsored by Nutricia and received a speaker fee, and his department has held a clinical update meeting sponsored by Abbott. David Hill has received support from SHS/Nutricia for clinical research, to attend scientific meetings, for consultations and to speak at sponsored meetings. Ralph Heine has been a member of the scientific advisory boards of Nutricia Australia and the Nestlé Nutrition Institute Oceania, and has received travel assistance and speaker fees from both companies to present at or attend scientific meetings. Jane Peake has been a speaker at meetings sponsored by SHS/Nutricia, Nestlé and Wyeth, and has had some travel expenses reimbursed. Susan Prescott has received an honorarium from Mead Johnson and is a member of the independent Scientific Advisory Board of Nestlé.

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