Tolerance development in cow's milk–allergic infants receiving amino acid–based formula: A randomized controlled trial

• Main Authors: Pantipa Chatchatee, Anna Nowak-Wegrzyn, Lars Lange, Suwat Benjaponpitak, Kok Wee Chong, Pasuree Sangsupawanich, Marleen T.J. van Ampting, Manon M. Oude Nijhuis, Lucien F. Harthoorn, Jane E. Langford, Jan Knol, Karen Knipping, Johan Garssen, Valerie Trendelenburg, Robert Pesek, Carla M. Davis, Antonella Muraro, Mich Erlewyn-Lajeunesse, Adam T. Fox, Louise J. Michaelis, Kirsten Beyer, Lee Noimark, Gary Stiefel, Uwe Schauer, Hamelman, Diego Peroni, Boner
• Other Authors: Nutricia Research, Netherlands
• Format: Article
• Published: 2022
• Subjects: Immunology and Microbiology; Medicine
• Online Access: https://repository.li.mahidol.ac.th/handle/123456789/74172
• Institution: Mahidol University

Background: Tolerance development is an important clinical outcome for infants with cow's milk allergy. Objective: This multicenter, prospective, randomized, double-blind, controlled clinical study (NTR3725) evaluated tolerance development to cow's milk (CM) and safety of an amino acid–based formula (AAF) including synbiotics (AAF-S) comprising prebiotic oligosaccharides (oligofructose, inulin) and probiotic Bifidobacterium breve M-16V in infants with confirmed IgE-mediated CM allergy. Methods: Subjects aged ≤13 months with IgE-mediated CM allergy were randomized to receive AAF-S (n = 80) or AAF (n = 89) for 12 months. Stratification was based on CM skin prick test wheal size and study site. After 12 and 24 months, CM tolerance was evaluated by double-blind, placebo-controlled food challenge. A logistic regression model used the all-subjects randomized data set. Results: At baseline, mean ± SD age was 9.36 ± 2.53 months. At 12 and 24 months, respectively, 49% and 62% of subjects were CM tolerant (AAF-S 45% and 64%; AAF 52% and 59%), and not differ significantly between groups. During the 12-month intervention, the number of subjects reporting at least 1 adverse event did not significantly differ between groups; however, fewer subjects required hospitalization due to serious adverse events categorized as infections in the AAF-S versus AAF group (9% vs 20%; P = .036). Conclusions: After 12 and 24 months, CM tolerance was not different between groups and was in line with natural outgrowth. Results suggest that during the intervention, fewer subjects receiving AAF-S required hospitalization due to infections.