NCT01728610已完成2 期
Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms (IBS-2)
Danisco4 个研究点 分布在 1 个国家目标入组 391 人开始时间: 2012年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 391
- 试验地点
- 4
- 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 a probiotic supplement on functional intestinal symptoms among subjects diagnosed with irritable bowel syndrome (IBS).
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 functional intestinal symptoms among subjects diagnosed with IBS according to Rome III criteria. Subjective assessment of bowel symptoms, quality of life, anxiety and depression and adequate relief will be assessed as with questionnaires as outcome measures. The intestinal microbiota will be analysed from faecal samples.
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 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.
结局指标
主要结局
Change in functional bowel symptoms
时间窗: 0 weeks, 4 weeks, 12 weeks
Validated questionnaire
次要结局
- Change in faecal microbiota(0 weeks, 4 weeks, 12 weeks)
- Change in anxiety and depression(0 weeks, 4 weeks and 12 weeks)
- Change in quality of life(0 weeks, 4 weeks, 12 weeks)
- Adequate relief(Weekly over 3 month intervention)
- Safety of investigational product(Throughout the intervention phase)
研究者
研究点 (4)
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