NCT03241355已完成不适用
Double-blind, Parallel, Randomized, (Placebo-controlled) Explorative Study on the Effect of a Mixture of Prebiotic Oligosaccharides on the Composition of Intestinal Microbiota and Selected Health Outcomes in Children 3 to 6 Years of Age
Beneo-Institute0 个研究点目标入组 258 人开始时间: 2013年9月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 258
- 主要终点
- Frequency of infectious disease episodes
研究概览
简要总结
The study aims to explore whether prophylactic dietary supplementation with prebiotic inulin-type fructans is able to influence the intestinal microbiota and the frequency of infectious disease episodes in kindergarten children during a winter period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is healthy at the time of pre-examination
- •Subject is aged 3-6 years at the time of pre-examination
- •Subject attends a kindergarten at the time of pre-examination
排除标准
- •congenital disease or malformation influencing the gastrointestinal System
- •children with congenital or acquired immunodeficiency
- •children with food intolerance, food allergy or metabolic disorder requiring special diet
- •children who regularly (more than 3 times per week) consumed products or food supplements containing prebiotics or probiotics
- •children who consumed antibiotics or laxatives within 14 days
- •children who had any infectious disease within 14 days at the time of pre-examination
结局指标
主要结局
Frequency of infectious disease episodes
时间窗: 24 weeks period
次要结局
- microbiota composition(24 weeks period)
研究者
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