Pediatric Allergy Unit, Bambino Gesù Hospital, Roma, Italy.
Azienda Ospedaliera Universitaria Integrata, Verona, Italy.
Immun Inflamm Dis. 2020 Jun;8(2):140-149. doi: 10.1002/iid3.286. Epub 2020 Feb 28.
Infants with cow'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.
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' 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.
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.
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.
患有牛奶过敏（CMA）的婴儿需要在 2 岁前使用替代配方。CMA 替代牛奶有三个要求：耐受性、营养充足性和成本效益。我们在此评估一种新的基于氨基酸的婴儿配方用于 CMA 管理的耐受性。
在一项 III/IV 期前瞻性、多中心、开放性、国际研究中，使用 Blemil Plus Elemental 通过 Neocate 作为安慰剂，对免疫球蛋白 E 介导的 CMA 的婴儿和儿童进行了新的氨基酸配方的双盲、安慰剂对照食物挑战诊断。如果耐受，研究配方将在 7 天内纳入患者的日常饮食中。第 7 天根据与 CMA 相关的症状、配方消耗量、营养和能量摄入以及人体测量数据评估疗效。
30 名儿童（17 名男性和 13 名女性；中位数年龄为 1.58 岁；范围为 0.08-12.83 岁）完成了开放性挑战，并且能够至少连续 7 天使用研究配方。在使用测试或对照配方的儿童中均未记录到过敏反应的迹象或症状，95%单侧置信区间下限超过 90%，表明没有过敏反应的受试者比例较高。16 名年龄小于 2 岁的患者继续进行可选扩展阶段。
研究配方符合美国儿科学会对低过敏性的标准，短期使用耐受性良好。在可选阶段，患者的生长未受到研究配方的阻碍。
