A well‐tolerated new amino acid–based formula for cow's milk allergy. Issue 2 (28th February 2020)

• Record Type: Journal Article
• Authors: Fierro, Vincenzo; Valluzzi, Rocco L.; Banzato, Claudia; Plaza, Ma A.; Bosque, Montserrat; Íbero, Marcel; Echeverría, Luis A. Z.; Mennini, Maurizio; Dahdah, Lamia; de Castellar, Roser; Tort, Gloria; Jiménez, Jesus
• Is Part Of: Immunity, inflammation and disease. Volume 8:Issue 2(2020)
• Page Start: 140
• Page End: 149
• Publication Date: 2020-02-28
• Subjects: Allergy<Processes -- amino acid formula -- children -- cow's milk allergy -- toddler; Immunology -- Periodicals; Immunity -- Periodicals; Inflammation -- Periodicals; 616.079
• DOI: 10.1002/iid3.286
• Languages: English
• ISSNs: 2050-4527

Abstract

Abstract: Objectives: Infants with cow&#39;s milk allergy (CMA) are in need of a substitute formula up to 2 years. The are three requisites for a substitute of milk in CMA: tolerability, nutritional adequacy, and cost‐effectiveness. We evaluate here the tolerability of a new amino acid–based infant formula for the management of CMA. Methods: In a phase III/IV prospective, multicentre, open‐label, international study, infants and children with immunoglobulin E‐mediated CMA were exposed to a diagnostic double‐blinded, placebo‐controlled food challenge with a new amino acid formula by Blemil Plus Elemental using Neocate as the placebo. If tolerant to it, the study formula was integrated into the patients&#39; usual daily diet for 7 days. Efficacy on day 7 was assessed in terms of symptoms associated with CMA, amount of formula consumed, nutritional and energy intake, and anthropometric data. Results: Thirty children (17 M and 13 F; median age, 1.58; range, 0.08‐12.83 years) completed the open challenge and were able to consume the study formula for at least 7 days. No signs or symptoms of allergic reactions were recorded among children assuming either the test or the control formula, with a lower 95% one‐sided confidence interval for the proportion of subjects who did not experience allergic reactions above 90%. Sixteen patient under the age of two continued with the optional extension phase. Conclusions: The study formula meets the American Academy of Pediatric criteria for hypoallergenicity and is well tolerated in short‐term use. During optional phase, growth of the patients was not hindered by the study formula. Abstract : This study provides data on a new amino acid formula, documenting the hypoallergenicity of such a preparation in a cohort of children with milk allergy. These children are in need of a substitute formula especially up to 2 years. We designed a study in compliance with the rules and procedures indicated by the American Academy of Pediatric regarding studies on new special formulas to be included in the therapeutic options.