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临床试验/NCT04164914
NCT04164914已完成不适用

Intestinal Microbiota Adaptation to Prebiotic Administration

Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年4月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Number of daily anal gas evacuations

研究概览

简要总结

Non-absorbable, fermentable residues in the diet increase intestinal gas production and induce gas-related symptoms, such as flatulence, abdominal bloating and distention; however, prebiotics, which are also fermented by colonic bacteria, have been shown to improve this type of symptoms. The aim is to demonstrate whether a prebiotic induces adaptive changes in metabolic activity of gut microbiota and colonic biomass that explain its beneficial effect on gas-related symptoms.

Single-centre, single arm, open label, proof-of-concept study in healthy subjects. The study will consist of a pre-administration phase (2 wk), an administration phase (4 wk) and a post-administration phase (2 wk). A soluble prebiotic fiber (resistant dextrin 14 g/d) will be administered during the 4 wk administration phase. During 4 days immediately before, at the beginning and at the end of the administration phase and at the end of the post-administration phase participants will be put on a standard diet and the following outcomes will be measured: a) number of gas evacuations during daytime for 2 days by means of an event marker; b) volume of gas evacuated via a rectal tube during 4 hours after a test meal, by means of a barostat; c) microbiota composition by fecal analysis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • 未提供

排除标准

  • •gastrointestinal symptoms
  • •recent (3 months) antibiotic intake
  • •change in dietary habits 4 weeks before

研究组 & 干预措施

Healthy subjects

Experimental

Prebiotic administration

干预措施: Prebiotic (Dietary Supplement)

结局指标

主要结局

Number of daily anal gas evacuations

时间窗: 28 days

Change in the number of anal gas evacuations measured by an event marker from beginning of treatment to end of treatment

次要结局

  • Volume of anal gas evacuation(28 days)
  • Microbiota composition by fecal analysis(28 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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