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Tolerance development in cow's milk-allergic infants receiving amino acid-based formula: A randomized controlled trial.
Chatchatee, Pantipa; Nowak-Wegrzyn, Anna; Lange, Lars; Benjaponpitak, Suwat; Chong, Kok Wee; Sangsupawanich, Pasuree; van Ampting, Marleen T J; Oude Nijhuis, Manon M; Harthoorn, Lucien F; Langford, Jane E; Knol, Jan; Knipping, Karen; Garssen, Johan; Trendelenburg, Valerie; Pesek, Robert; Davis, Carla M; Muraro, Antonella; Erlewyn-Lajeunesse, Mich; Fox, Adam T; Michaelis, Louise J; Beyer, Kirsten.
Affiliation
  • Chatchatee P; Pediatric Allergy and Clinical Immunology Research Unit, Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.
  • Nowak-Wegrzyn A; Allergy and Immunology, Department of Pediatrics, New York University Langone Health, New York, NY; Department of Pediatrics, Gastroenterology and Nutrition, Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland.
  • Lange L; St Marien Hospital, Bonn, Germany.
  • Benjaponpitak S; Pediatric Allergy and Immunology Division, Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
  • Chong KW; Allergy Service, Department of Paediatric Medicine, KK Women's & Children's Hospital, Singapore, Singapore.
  • Sangsupawanich P; Department of Pediatrics, Faculty of Medicine, Prince of Songkla University, Hat Yai, Thailand.
  • van Ampting MTJ; Danone Nutricia Research, Utrecht, The Netherlands. Electronic address: marleen.vanampting@nutricia.com.
  • Oude Nijhuis MM; Danone Nutricia Research, Utrecht, The Netherlands.
  • Harthoorn LF; Danone Nutricia Research, Utrecht, The Netherlands.
  • Langford JE; Danone Nutricia Research, Utrecht, The Netherlands.
  • Knol J; Danone Nutricia Research, Utrecht, The Netherlands; Laboratory of Microbiology, Wageningen University, Wageningen, The Netherlands.
  • Knipping K; Danone Nutricia Research, Utrecht, The Netherlands.
  • Garssen J; Danone Nutricia Research, Utrecht, The Netherlands; Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
  • Trendelenburg V; Department of Pediatric Pneumology, Immunology, and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.
  • Pesek R; Arkansas Children's Hospital, Little Rock, Ark.
  • Davis CM; Texas Children's Hospital, Baylor College of Medicine, Houston, Tex.
  • Muraro A; Food Allergy Referral Centre, Padua University Hospital, Padua, Italy.
  • Erlewyn-Lajeunesse M; University Hospitals Southampton, Southampton, United Kingdom.
  • Fox AT; Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.
  • Michaelis LJ; Great North Children's Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, United Kingdom.
  • Beyer K; Department of Pediatric Pneumology, Immunology, and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.
J Allergy Clin Immunol ; 149(2): 650-658.e5, 2022 02.
Article in En | MEDLINE | ID: mdl-34224785
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.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Milk Hypersensitivity / Infant Formula / Amino Acids / Immune Tolerance Type of study: Clinical_trials / Observational_studies Limits: Female / Humans / Infant / Male / Newborn Language: En Journal: J Allergy Clin Immunol Year: 2022 Document type: Article Affiliation country: Thailand Country of publication: United States

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Milk Hypersensitivity / Infant Formula / Amino Acids / Immune Tolerance Type of study: Clinical_trials / Observational_studies Limits: Female / Humans / Infant / Male / Newborn Language: En Journal: J Allergy Clin Immunol Year: 2022 Document type: Article Affiliation country: Thailand Country of publication: United States