跳至主要内容
临床试验/NCT02618239
NCT02618239已完成不适用

Effect of Prebiotics on Intestinal Gas Production, Microbiota and Digestive Symptoms

Hospital Universitari Vall d'Hebron Research Institute0 个研究点目标入组 20 人开始时间: 2013年11月最近更新:
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
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 changes in metabolic activity of gut microbiota and colonic biomass induced by prebiotics.

Healthy subjects (n=20) will be administered a prebiotic (Galacto-oligo-saccharide; 2.8 g/d) for 3 weeks; they will also receive a standard diet during three days. The following outcomes will be measured immediately before, at the beginning and at the end of the treatment: a) number of gas evacuations during daytime for 2 days on the standard diet, 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

入选标准

  • 未提供

排除标准

  • gastrointestinal symptoms
  • recent (3 months) antibiotic intake
  • recent (3 months) change of diet
  • recent (3 months) gastroenteritis

研究组 & 干预措施

Healthy subjects

Experimental

Bimuno Galacto-oligo-saccharide administration 2.7 g/d x 3 weeks

干预措施: Bimuno Galacto-oligo-saccharide (Dietary Supplement)

结局指标

主要结局

Number of daily anal gas evacuations

时间窗: Change from beginning of treatment (mean of days 2 and 3) to end of treatment (mean of days 20 and 21)

次要结局

  • Volume of anal gas evacuation(Change from beginning of treatment (day 3) to end of treatment (day 21))

研究者

申办方类型
Other
责任方
Sponsor

相似试验