Icahn School of Medicine at Mount Sinai, New York, NY 10029-5674, USA.
Nestlé Nutrition, Arlington, VA 22209, USA.
Nutrients. 2019 Jun 26;11(7):1447. doi: 10.3390/nu11071447.
We sought to determine whether an extensively hydrolyzed formula (EHF) supplemented with two human milk oligosaccharides (HMO) was tolerated by infants with cow's milk protein allergy (CMPA).
A whey-based EHF (Test formula) containing 2'fucosyl-lactose (2'FL) and lacto-N-neotetraose (LNnT) was assessed for clinical hypoallergenicity and safety. The Control formula was a currently marketed EHF without HMO. Children with CMPA, aged 2 months to 4 years, were assessed by double-blind, placebo-controlled food challenges (DBPCFC) to both formulas, in randomized order. If both DBPCFC were negative, subjects participated in a one-week, open food challenge (OFC) with the Test formula. Symptoms and adverse events were recorded. Hypoallergenicity was accepted if at least 90% (with 95% confidence intervals) of subjects tolerated the Test formula.
Of the 82 children with CMPA that were screened, 67 (intention-to-treat [ITT] cohort-mean age 24.5 ± 13.6 months; range 2-57; 45 [67.2%] male) were randomized to receive either the Test or the Control formula during the first DBPCFC. Of these, 64 children completed at least one DBPCFC (modified intention-to-treat [mITT] cohort). Three children were excluded due to protocol deviations (per protocol [PP] cohort; 61). There was one allergic reaction to the Test, and one to the Control formula. On the mITT analysis, 63 out of 64 (98.4%; 95% CI lower bound 92.8%), and on the PP analysis 60 out of 61 (98.4%; 95% CI lower bound 92.5%) participants tolerated the Test formula, confirming hypoallergenicity.
The whey-based EHF supplemented with 2'FL and LNnT met the clinical hypoallergenicity criteria and can be recommended for the management of CMPA in infants and young children.
我们旨在确定含有两种人乳寡糖（HMO）的高度水解配方（EHF）是否可被牛乳蛋白过敏（CMPA）婴儿耐受。
一种基于乳清的 EHF（测试配方），含有 2'岩藻糖基乳糖（2'FL）和乳-N-新四糖（LNnT），评估其临床低过敏性和安全性。对照配方是一种目前市售的不含 HMO 的 EHF。2 个月至 4 岁的 CMPA 儿童通过双盲、安慰剂对照食物挑战（DBPCFC），随机顺序接受两种配方的评估。如果两次 DBPCFC 均为阴性，则受试者参加为期一周的、开放食物挑战（OFC），用测试配方。记录症状和不良反应。如果至少 90%（置信区间为 95%）的受试者耐受测试配方，则接受低过敏性。
在筛选的 82 名 CMPA 儿童中，67 名（意向治疗[ITT]队列，平均年龄 24.5±13.6 个月；范围 2-57；45 名[67.2%]男性）在第一次 DBPCFC 中随机接受测试或对照配方。其中，64 名儿童完成了至少一次 DBPCFC（改良意向治疗[mITT]队列）。由于方案偏差，有 3 名儿童被排除（方案人群[PP]队列；61 名）。有 1 名对测试配方过敏，1 名对对照配方过敏。在 mITT 分析中，64 名中的 63 名（98.4%；95%CI 下限 92.8%），在 PP 分析中，61 名中的 60 名（98.4%；95%CI 下限 92.5%）受试者耐受测试配方，确认低过敏性。
基于乳清的 EHF 补充 2'FL 和 LNnT 符合临床低过敏性标准，可推荐用于婴幼儿 CMPA 的管理。
