Hypoallergenicity Assessment of an Extensively Hydrolyzed Whey-protein Formula in Cow's Milk Allergic Infants

Overview

Journal Pediatr Allergy Immunol

Specialty Pediatrics

Date 2022 Jun 27

PMID 35754130

Authors

Lamia Dahdah

Mieke Roelofs

Karen Knipping

Esther de Vries

Anneke Rijnierse

Johan Garssen

Paul L P Brand

Alessandro Fiocchi

Affiliations

Soon will be listed here.

Abstract

Background: Extensively hydrolyzed formulas are recommended for the dietary management of infants with cow's milk allergy (CMA).

Objectives: Hypoallergenicity, growth, and gastrointestinal (GI) tolerability of a new extensively hydrolyzed whey-protein formula (eHWF) in CMA children were assessed.

Methods: In this prospective, randomized, international, multi-center study (Trial NL3889), 34 children with confirmed CMA (74% IgE-mediated) underwent a double-blind, placebo-controlled food challenge (DBPCFC) with an eHWF developed with non-porcine enzymes, supplemented with prebiotic short-chain galacto- and long-chain fructo-oligosaccharides (0.8 g/L, ratio 9:1), arachidonic acid (0.35/100 g), and docosahexaenoic acid (0.35/100 g). If tolerant to the eHWF, children participated in a 7-day open food challenge with this eHWF. Anthropometrics and GI tolerability were assessed in an optional 16-weeks follow-up.

Results: Of the 34 children who started the DBPCFC with the eHWF, 25 subjects (19 boys, mean age: 61 weeks, 18 with IgE-mediated CMA) completed the DBPCFC and 7-day open challenge without major protocol deviations and tested negative at both challenges. One child experienced a late moderate eczematous allergic reaction in the optional follow-up period, indicating the need for close monitoring of subjects starting new formula. Weight and length gain followed the World Health Organization growth curves. Changes in frequency and consistency of stools upon test formula intake were transient.

Conclusions: The newly developed eHWF is a suitable option in CMA treatment as all subjects tolerated the product. This result is in line with the international criteria for hypoallergenicity (American Academy of Pediatrics) that state that more than 90% of CMA children must tolerate the formula. Use of the formula is also associated with normal growth curves and GI tolerability.

Trial Registration: Trial NL3889, https://www.trialregister.nl/trial/3889.

Citing Articles

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PMID: 39049879 PMC: 11268007. DOI: 10.1177/2333794X241260261.

An In Vitro and In Vivo Translational Research Approach for the Assessment of Sensitization Capacity and Residual Allergenicity of an Extensive Whey Hydrolysate for Cow's Milk-Allergic Infants.

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Hypoallergenicity assessment of an extensively hydrolyzed whey-protein formula in cow's milk allergic infants.

Dahdah L, Roelofs M, Knipping K, de Vries E, Rijnierse A, Garssen J Pediatr Allergy Immunol. 2022; 33(6):e13814.

PMID: 35754130 PMC: 9542408. DOI: 10.1111/pai.13814.

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