NCT00806104已完成不适用
Effect of Dietary Supplementation With Fructo-oligosaccharides on Visceral Sensitivity and on Taxonomic and Functional Composition of Intestinal Microbiota of IBS Patients
Beghin-Meiji4 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2009年3月1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
- 60
- 试验地点
- 4
- 主要终点
- rectal sensitivity
研究概览
简要总结
Fructo-oligosaccharides are known as prebiotic ingredients to modulate the composition of the intestinal microbiota and particularly to stimulate the growth of Bifidobacteria. Imbalance of the intestinal microbiota such as reduction of Bifidobacteria is implicated in Irritable Bowel Syndrome (IBS). Thus the objective of the study is to evaluate the effect of fructo-oligosaccharides to improve IBS score and to explore which modifications of the microbiota are responsible of this improvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •IBS subjects according to Rome III criteria
- •Incomfort below or equivalent to 30mmHg during Tensostat test
- •between 18 and 60 years
- •no antibiotic treatment for the last 2 months
- •less than 20g of dietary fibres consummed per day
- •no analgesic treatment
- •no treatment for intestinal transit
排除标准
- •subjects suffering from diabetes, colic cancer, inflammatory bowel disease, dysthyroidy, Hirschprung disease, anorexia
- •excessive consumption of alcohol or tobacco
- •participating to another clinical study
- •pregnant women
- •antidepressor or anxiolytic treatment
结局指标
主要结局
rectal sensitivity
时间窗: 4 weeks
次要结局
- taxonomic composition of intestinal microbiota(4 weeks)
研究者
研究点 (4)
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