Safety and tolerance of a new extensively hydrolyzed rice protein-based formula in the management of infants with cow’s milk protein allergy

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Abstract

Guidelines recommend the use of extensively hydrolyzed cow’s milk protein-based formulas (eHF) in the treatment of infants with cow’s milk protein allergy (CMPA). Extensively hydrolyzed rice protein infant formula (eRHF) has recently become available and could offer a valid alternative. A prospective trial was performed to evaluate the hypo-allergenicity and safety of a new eRHF in infants with a confirmed CMPA. Patients were fed the study formula for 6 months. Clinical tolerance of the eRHF was evaluated with a symptom-based score (SBS) and growth (weight and length) was monitored. Forty infants (mean age, 3.4 months; range, 1–6 months) with CMPA confirmed by a food challenge were enrolled. All infants tolerated the eRHF and the SBS significantly decreased as of the first month of intervention. Moreover, the eRHF allowed a catch-up to normal weight gain as of the first month as well as a normalization of the weight-for-age, weight-for length, and BMI z-scores within the 6-month study period. Conclusion: In accordance with current guidelines, this eRHF was tolerated by more than 90 % of children with proven CMPA with a 95 % confidence interval. This eRHF is an adequate and safe alternative to cow milk-based eHF.

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Most cited references 12

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Guidelines for the diagnosis and management of cow's milk protein allergy in infants.

David Hill, A P Oranje, Martin Brueton … (2007)

Our aim was to develop guidance for general paediatricians and primary care physicians in diagnosing and managing cow's milk protein allergy in infants. The guidelines were developed by discussion based on existing national recommendations and standards, clinical experience and, whenever possible, evidence from the literature. Separate algorithms cover breast-fed and formula-fed infants. The recommendations emphasise the importance of comprehensive history taking and careful physical examination. Patients with severe symptoms need to be referred to a specialist. Elimination of cow's milk protein from the infant's or mother's diet and challenges are the gold standard for diagnosis. This guidance is intended as a basis for local discussion, implementation and prospective evaluation. The algorithms should be regularly assessed using clinical audit standards. Once validated, the diagnostic framework could provide a standardised approach in epidemiological and therapeutic studies.

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Safety and efficacy of a new extensively hydrolyzed formula for infants with cow's milk protein allergy.

B Niggemann, A. von Berg, C Bollrath … (2008)

Cow's milk protein allergy (CMPA) is best treated by complete elimination of cow's milk from the diet. For infants with CMPA who cannot be breast-fed, formulas based on extensively hydrolyzed proteins or on amino acids are the preferred substitutes for cow's milk-based formulas. In this study, we compared the tolerance and growth of infants with CMPA who were fed a new extensively hydrolyzed formula containing lactose (eHF) with those who were fed an amino acid formula (AAF). This was a prospective, multi-center, randomized, reference-controlled study. Seventy-seven infants <12 months old with suspected CMPA were enrolled. In 66 of these, CMPA was confirmed by oral challenge in a double-blind, placebo-controlled food challenge (DBPCFC) or by a medical history of severe allergic reaction to cow's milk and a positive skin prick test. These infants were then tested for their reaction to eHF and AAF in a DBPCFC. All infants tolerated both formulas and were randomized to receive either eHF (n = 34) or AAF (n = 32) for 180 days. Growth (weight, length, and head circumference) and tolerance [skin, gastro-intestinal, and respiratory tract symptoms of allergy] were evaluated after 30, 60, 90, and 180 days. There were no significant differences between the two groups in any of the growth measurements. Length and head circumference were similar to Euro-growth standards, but weight was slightly lower. Gastro-intestinal and respiratory tract symptoms of allergy were also similar in the two groups. However, whereas SCORAD scores for atopic dermatitis remained constant throughout the study in infants-fed eHF, there was a slight decrease in those fed AAF. Infants-fed eHF had significantly fewer incidents of vomiting than infants-fed AAF and a significantly higher frequency of soft stools. The new eHF is safe and well tolerated in infants diagnosed with CMPA.

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Author and article information

Contributors

Yvan Vandenplas: +32-24775780 , +32-24775784 , yvan.vandenplas@uzbrussel.be

Elisabeth De Greef: elisabeth.degreef@uzbrussel.be

Bruno Hauser: bruno.hauser@uzbrussel.be

Journal

Journal ID (nlm-ta): Eur J Pediatr

Journal ID (iso-abbrev): Eur. J. Pediatr

Title: European Journal of Pediatrics

Publisher: Springer Berlin Heidelberg (Berlin/Heidelberg )

ISSN (Print): 0340-6199

ISSN (Electronic): 1432-1076

Publication date (Electronic): 12 April 2014

Publication date PMC-release: 12 April 2014

Publication date (Print): 2014

Volume: 173

Pages: 1209-1216

Affiliations

Department of Pediatrics, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium

Author notes

Communicated by David Nadal

Article

Publisher ID: 2308

DOI: 10.1007/s00431-014-2308-4

PMC ID: 4134482

PubMed ID: 24723091

SO-VID: 06c9dd65-a014-413c-8c76-79a6ec1785c7

License:

Open Access This article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.

History

Date received : 26 December 2013

Date revision received : 3 March 2014

Date accepted : 24 March 2014

Custom metadata

ScienceOpen disciplines: Pediatrics

Keywords: cow’s milk protein allergy,extensive hydrolysate,extensively hydrolyzed rice protein formula

Data availability:

ScienceOpen disciplines: Pediatrics

Keywords: cow’s milk protein allergy, extensive hydrolysate, extensively hydrolyzed rice protein formula

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