NL-OMON23678已完成不适用

A randomized, double-blind, placebo-controlled intervention study to assess the therapeutic effect of an extensively hydrolyzed infant formula with an added synbiotic mixture in infants with atopic dermatitis.

This clinical study will be performed within TOP Institute Pharma (project T1-501). Besides Danone Research, also the Academic Medical Center (AMC) Amsterdam, Wilhelmina Children's Hospital (WKZ) Utrecht, VU University Amsterdam, and the Utrecht Institute for Pharmaceutical Sciences (UIPS) will participate in the TOP Institute Pharma project. Danone Research shall take care of the Sponsor responsibilities as defined by ICH-GCP'.0 个研究点目标入组 144 人开始时间: 待定最近更新: 2024年2月28日

研究概览

简要总结

Hulshof L, Overbeek SA, Wyllie AL, Chu MLJN, Bogaert D, de Jager W, Knippels LMJ, Sanders EAM, van Aalderen WMC, Garssen J, Van ’t Land B, Sprikkelman AB. Exploring Immune Development in Infants With Moderate to Severe Atopic Dermatitis. Front Immunol., 2018;9:630.

研究设计

研究类型: Interventional

入排标准

入选标准

•1. Infants/children with atopic dermatitis;
•2. Between 0-8 months of age;

排除标准

•1. Intolerance for any other component of the study product(s);
•2. History of anaphylactic reaction to cow's milk protein, including severe cardiovascular symptoms (shock), severe laryngeal edema, and bronchus obstruction;

研究者

发起方

This clinical study will be performed within TOP Institute Pharma (project T1-501). Besides Danone Research, also the Academic Medical Center (AMC) Amsterdam, Wilhelmina Children's Hospital (WKZ) Utrecht, VU University Amsterdam, and the Utrecht Institute for Pharmaceutical Sciences (UIPS) will participate in the TOP Institute Pharma project. Danone Research shall take care of the Sponsor responsibilities as defined by ICH-GCP'.

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