Effect of Probiotic Supplement on Bowel Function
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Change in functional bowel symptoms
研究概览
简要总结
The purpose of this study is to analyse the effect of probiotic supplement on symptoms of irritable bowel syndrome.
详细描述
The aim of the intervention is to analyse the effect of a probiotic supplement in a dose-responsive set up on symptoms of irritable bowel syndrome (IBS). Fulfillment of Rome III criteria will be used as inclusion criterion. Subjective assessment of bowel symptoms, IBS-related quality of life and adequate relief will be assessed as outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 18 to 65 with functional bowel symptoms and fulfilling Rome III criteria for IBS will be recruited. Sufficient general health and orientation for participating in the study is required and will be evaluated by the MDs.
排除标准
- •Diagnosed or suspected organic gastrointestinal diseases or severely impaired general health are exclusion criteria.
研究组 & 干预措施
Probiotic low
Lower dose of probiotic supplement
干预措施: Probiotic supplement (Dietary Supplement)
Placebo
干预措施: Probiotic supplement (Dietary Supplement)
Probiotic high
Higher dose of probiotic supplement
干预措施: Probiotic supplement (Dietary Supplement)
结局指标
主要结局
Change in functional bowel symptoms
时间窗: 0 weeks, 6 weeks, 12 weeks
Validated questionnaire
次要结局
- Adequate relief(Weekly over 3 month intervention)
- Change in faecal microbiota(0 weeks, 6 weeks, 12 weeks)
- Change in quality of life(0 weeks, 6 weeks, 12 weeks)