{"doi":"10.1016/j.jaci.2021.06.025","title":"Tolerance development in cow’s milk–allergic infants receiving amino acid–based formula: A randomized controlled trial","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.","journal":"Journal of Allergy and Clinical Immunology","year":2021,"id":162746,"datarank":0.5742962094733643,"base_score":3.828641396489095,"endowment":3.828641396489095,"self_citation_contribution":0.5742962094733643,"citation_network_contribution":0.0,"self_endowment_contribution":0.5742962094733643,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":45,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9644,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2021-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":241621,"name":"Anna Nowak‐Węgrzyn","orcid":"0000-0002-0960-9854","position":1,"is_corresponding":false},{"id":680370,"name":"Lars Lange","orcid":"0000-0003-1104-5848","position":2,"is_corresponding":false},{"id":680371,"name":"Suwat Benjaponpitak","orcid":"0000-0002-3711-8526","position":3,"is_corresponding":false},{"id":680372,"name":"Kok Wee Chong","orcid":"0000-0002-6530-6348","position":4,"is_corresponding":false},{"id":680373,"name":"Pasuree Sangsupawanich","orcid":"0000-0002-2295-533X","position":5,"is_corresponding":false},{"id":680374,"name":"Marleen T. J. van Ampting","orcid":"0000-0001-5545-9060","position":6,"is_corresponding":false},{"id":681172,"name":"Manon M. Oude Nijhuis","orcid":null,"position":7,"is_corresponding":false},{"id":201486,"name":"Lucien F. Harthoorn","orcid":null,"position":8,"is_corresponding":false},{"id":681173,"name":"Jane E. Langford","orcid":null,"position":9,"is_corresponding":false},{"id":680375,"name":"Jan Knol","orcid":"0000-0002-2103-5961","position":10,"is_corresponding":false},{"id":680376,"name":"Karen Knipping","orcid":"0000-0002-3700-9047","position":11,"is_corresponding":false},{"id":352562,"name":"Johan Garssen","orcid":"0000-0002-8678-9182","position":12,"is_corresponding":false},{"id":680377,"name":"Valérie Trendelenburg","orcid":"0000-0003-4401-5899","position":13,"is_corresponding":false},{"id":611250,"name":"Robert D. Pesek","orcid":null,"position":14,"is_corresponding":false},{"id":273994,"name":"Carla M. 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