Tolerance development in cow's milk–allergic infants receiving amino acid–based formula: A randomized controlled trial
Issued Date
2022-02-01
Resource Type
ISSN
00916749
eISSN
10976825
Scopus ID
2-s2.0-85111563011
Pubmed ID
34224785
Journal Title
Journal of Allergy and Clinical Immunology
Volume
149
Issue
2
Start Page
650
End Page
658.e5
Rights Holder(s)
SCOPUS
Bibliographic Citation
Journal of Allergy and Clinical Immunology Vol.149 No.2 (2022) , 650-658.e5
Suggested Citation
Chatchatee P., Nowak-Wegrzyn A., Lange L., Benjaponpitak S., Chong K.W., Sangsupawanich P., van Ampting M.T.J., Oude Nijhuis M.M., Harthoorn L.F., Langford J.E., Knol J., Knipping K., Garssen J., Trendelenburg V., Pesek R., Davis C.M., Muraro A., Erlewyn-Lajeunesse M., Fox A.T., Michaelis L.J., Beyer K., Noimark L., Stiefel G., Schauer U., Hamelman, Peroni D., Boner Tolerance development in cow's milk–allergic infants receiving amino acid–based formula: A randomized controlled trial. Journal of Allergy and Clinical Immunology Vol.149 No.2 (2022) , 650-658.e5. 658.e5. doi:10.1016/j.jaci.2021.06.025 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/85035
Title
Tolerance development in cow's milk–allergic infants receiving amino acid–based formula: A randomized controlled trial
Author(s)
Chatchatee P.
Nowak-Wegrzyn A.
Lange L.
Benjaponpitak S.
Chong K.W.
Sangsupawanich P.
van Ampting M.T.J.
Oude Nijhuis M.M.
Harthoorn L.F.
Langford J.E.
Knol J.
Knipping K.
Garssen J.
Trendelenburg V.
Pesek R.
Davis C.M.
Muraro A.
Erlewyn-Lajeunesse M.
Fox A.T.
Michaelis L.J.
Beyer K.
Noimark L.
Stiefel G.
Schauer U.
Hamelman
Peroni D.
Boner
Nowak-Wegrzyn A.
Lange L.
Benjaponpitak S.
Chong K.W.
Sangsupawanich P.
van Ampting M.T.J.
Oude Nijhuis M.M.
Harthoorn L.F.
Langford J.E.
Knol J.
Knipping K.
Garssen J.
Trendelenburg V.
Pesek R.
Davis C.M.
Muraro A.
Erlewyn-Lajeunesse M.
Fox A.T.
Michaelis L.J.
Beyer K.
Noimark L.
Stiefel G.
Schauer U.
Hamelman
Peroni D.
Boner
Author's Affiliation
Great North Children's Hospital
Nutricia Research, Netherlands
Utrechts Instituut voor Farmaceutische Wetenschappen
St. Marien Hospital, Bonn
Chulalongkorn University
Azienda Ospedale Università Padova
Charité – Universitätsmedizin Berlin
NYU Grossman School of Medicine
Uniwersytet Warminsko-Mazurski w Olsztynie
Faculty of Medicine Ramathibodi Hospital, Mahidol University
KK Women's And Children's Hospital
Prince of Songkla University
Guy's and St Thomas' NHS Foundation Trust
Wageningen University & Research
Arkansas Children's Hospital
Baylor College of Medicine
University Hospital Southampton NHS Foundation Trust
Nutricia Research, Netherlands
Utrechts Instituut voor Farmaceutische Wetenschappen
St. Marien Hospital, Bonn
Chulalongkorn University
Azienda Ospedale Università Padova
Charité – Universitätsmedizin Berlin
NYU Grossman School of Medicine
Uniwersytet Warminsko-Mazurski w Olsztynie
Faculty of Medicine Ramathibodi Hospital, Mahidol University
KK Women's And Children's Hospital
Prince of Songkla University
Guy's and St Thomas' NHS Foundation Trust
Wageningen University & Research
Arkansas Children's Hospital
Baylor College of Medicine
University Hospital Southampton NHS Foundation Trust
Other Contributor(s)
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.