牛乳过敏婴儿的深度水解乳清蛋白配方的低变应原性评估。

Hypoallergenicity assessment of an extensively hydrolyzed whey-protein formula in cow's milk allergic infants.

机构信息

Allergy Unit, Pediatric University Department, Bambino Gesù Children's Hospital, Rome, Italy.

Danone Nutricia Research, Utrecht, the Netherlands.

出版信息

Pediatr Allergy Immunol. 2022 Jun;33(6):e13814. doi: 10.1111/pai.13814.

DOI:10.1111/pai.13814

PMID:35754130

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9542408/

Abstract

BACKGROUND

Extensively hydrolyzed formulas are recommended for the dietary management of infants with cow's milk allergy (CMA).

OBJECTIVES

Hypoallergenicity, growth, and gastrointestinal (GI) tolerability of a new extensively hydrolyzed whey-protein formula (eHWF) in CMA children were assessed.

METHODS

In this prospective, randomized, international, multi-center study (Trial NL3889), 34 children with confirmed CMA (74% IgE-mediated) underwent a double-blind, placebo-controlled food challenge (DBPCFC) with an eHWF developed with non-porcine enzymes, supplemented with prebiotic short-chain galacto- and long-chain fructo-oligosaccharides (0.8 g/L, ratio 9:1), arachidonic acid (0.35/100 g), and docosahexaenoic acid (0.35/100 g). If tolerant to the eHWF, children participated in a 7-day open food challenge with this eHWF. Anthropometrics and GI tolerability were assessed in an optional 16-weeks follow-up.

RESULTS

Of the 34 children who started the DBPCFC with the eHWF, 25 subjects (19 boys, mean age: 61 weeks, 18 with IgE-mediated CMA) completed the DBPCFC and 7-day open challenge without major protocol deviations and tested negative at both challenges. One child experienced a late moderate eczematous allergic reaction in the optional follow-up period, indicating the need for close monitoring of subjects starting new formula. Weight and length gain followed the World Health Organization growth curves. Changes in frequency and consistency of stools upon test formula intake were transient.

CONCLUSIONS

The newly developed eHWF is a suitable option in CMA treatment as all subjects tolerated the product. This result is in line with the international criteria for hypoallergenicity (American Academy of Pediatrics) that state that more than 90% of CMA children must tolerate the formula. Use of the formula is also associated with normal growth curves and GI tolerability.

TRIAL REGISTRATION

Trial NL3889, https://www.trialregister.nl/trial/3889.

摘要

背景

对于牛奶蛋白过敏（CMA）的婴儿，推荐使用深度水解配方进行饮食管理。

目的

评估一种新的深度水解乳清蛋白配方（eHWF）在 CMA 儿童中的低变应原性、生长和胃肠道（GI）耐受性。

方法

在这项前瞻性、随机、国际、多中心研究（NL3889 试验）中，34 名确诊的 CMA 儿童（74%为 IgE 介导）接受了一种新型、非猪源酶制备的 eHWF 的双盲、安慰剂对照食物挑战（DBPCFC），该配方添加了短链半乳糖和长链果糖低聚糖（0.8 g/L，比例为 9:1）、花生四烯酸（0.35/100 g）和二十二碳六烯酸（0.35/100 g）作为益生元。如果对 eHWF 耐受，儿童将参加为期 7 天的开放性食物挑战。在可选的 16 周随访中评估人体测量学和 GI 耐受性。

结果

在开始用 eHWF 进行 DBPCFC 的 34 名儿童中，25 名受试者（19 名男孩，平均年龄：61 周，18 名 IgE 介导的 CMA）完成了 DBPCFC 和 7 天的开放性挑战，没有主要方案偏差，且在两次挑战中均呈阴性。一名儿童在可选的随访期间出现迟发性中度湿疹样过敏反应，这表明需要密切监测开始使用新配方的受试者。体重和身长增长符合世界卫生组织生长曲线。测试配方摄入后粪便频率和稠度的变化是暂时的。