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