Tolerance development in cow’s milk–allergic infants receiving amino acid–based formula: A randomized controlled trial - 03/02/22
, Manon M. Oude Nijhuis, PhD h, Lucien F. Harthoorn, PhD h, Jane E. Langford, PhD h, Jan Knol, PhD h, i, Karen Knipping, MSc h, Johan Garssen, PhD h, j, Valerie Trendelenburg, PhD k, Robert Pesek, MD l, Carla M. Davis, MD m, Antonella Muraro, MD n, Mich Erlewyn-Lajeunesse, MD o, Adam T. Fox, MD p, Louise J. Michaelis, MD, PhD q, Kirsten Beyer, MD kon behalf of the
PRESTO study team∗
Abstract |
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.
Le texte complet de cet article est disponible en PDF.Graphical abstract |
Key words : Cow’s milk allergy, prebiotics, probiotics, amino acid–based formula, oral tolerance, infection, synbiotics
Abbreviations used : AAF, AAF-S, AE, ASR, CM, CMA, DBPCFC, eHF, ER/CC, SAE, SCORAD, SPT
Plan
| This study was funded by Danone Nutricia Research, Utrecht, The Netherlands. |
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| Disclosure of potential conflict of interest: A. Nowak-Wegrzyn reports royalty payments from UpToDate; research grants from Nutricia, Nestlé, Astellas Pahrma, NIAID, and DBV Technologies; personal fees from Nestlé, Nutricia/Danone, Novartis, and Regeneron; serves the American College of Allergy, Asthma, and Immunology as deputy editor of the Annals of Allergy, Asthma, and Immunology and is a member of the American Board of Allergy and Immunology outside the submitted work; and is on the medical advisory board (unpaid) of the International FPIES Association. L. Lange received lecture fees from Nutricia, Nestlé Nutritional Institute, Allergopharma, Infectopharm, HAL Allergy, and DBV Technologies; and received consulting fees from Nestlé Nutritional Institute, DBV Technologies, Infectopharm, and Aimmune outside the submitted work. M. van Ampting, M. Oude Nijhuis, J. Langford, J. Knol, K. Knipping, and J. Garssen are employees of Danone Nutricia Research; the content of this article does not influence their salary. V. Trendelenburg received lecture fees from Danone/Nutricia. C. M. Davis receives research grant support from the National Institutes of Health/National Institute of Allergy and Infectious Disease, Food Allergy Research and Education, DBV Technologies, Aimmune Therapeutics, Nutricia North America, Regeneron Pharmaceuticals, and the Scurlock Foundation; and is a consultant for Moonlight Therapeutics. A. Muraro has received speaker’s fees from DVB Technologies, Aimmune, Meda-Mylan, Nutricia/Danone, Nestlé Health Institute, Nestlé Purina, and Regeneron. M. Erlewyn-Lajeunesse has undertaken clinical research with Danone/Nutricia and Abbott Nutrition and was a member of the IMAP milk allergy guidelines group. A. T. Fox has received research funding from ALK-Abello and Danone and consultancy fees from Stallergenes Greer, DBV, Aimmune, Danone, and Mead Johnson; and is president of BSACI, previous director of KCL Allergy Academy, and trustee of Allergy UK, all of which receive commercial sponsorship. L. J. Michaelis reports consultant arrangements with advisory boards at Danone and Novartis, and speakers’ bureau participation for Danone, Mead Johnson, and Regeneron; involvement in commercial clinical trials at Danone and Regeneron; and membership in BSACI, EAACI, and BPAIIG. K. Beyer has received lecture fees from Aimmune, Allergopharma, Bencard, Danone/Nutrica, Infectopharm, Meda Pharma/Mylan, Nestlé, and ThermoFisher, and consulting fees from Aimmune, ALK, Bausch & Lomb, Bencard, Danone/Nutrica, DBV, Hipp, Hycor, Infectopharm, Mabylon, Meda Pharma/Mylan, Nestlé, and Novartis. L. Harthoorn is a former Danone Nutricia Research employee and has no conflict of interest. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 149 - N° 2
P. 650 - février 2022 Retour au numéro
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