NCT01613456已完成不适用
Effect of S.Cerevisiae vs Placebo on the Improvement of Gastrointestinal Disorders,Especially During Irritable Bowel Syndrome. Randomized, Double-blind Study
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
- 364
- 试验地点
- 1
- 主要终点
- Change from baseline in discomfort score,obtained by Daily Likert Scale averaged by week
研究概览
简要总结
The main purpose of this study is the effect of the probiotic yeast Saccharomyces cerevisiae CNCM I-3856 on abdominal pain or intestinal discomfort in patients presenting with the irritable bowel syndrome (IBS)
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBS subject meeting the Rome III criteria , with a discomfort or pain present more than 1 day per week in whom organic causes of their symptoms have been excluded
- •IBS-C with less than 3 complete spontaneous bowel movements/week
- •IBS-D with at least 2 or more days/week one stool which has consistency of type 6 or 7 Bristol stool score
- •Subject able of and willing to comply with the protocol and to give their written informed consents
排除标准
- •History of chronic gastrointestinal disorders
- •History of lactose intolerance
- •History of gluten intolerance
- •Treatment able to influence IBS, modifying intestinal sensitivity and motility (antidepressants,opioid, narcotic analgesics)
- •Eating disorders
- •Pregnancy in progress
研究组 & 干预措施
Placebo
Placebo Comparator
Dicalcium phosphate, Maltodextrin and Magnesium stearate.
干预措施: Placebo (Dietary Supplement)
Saccharomyces cerevisiae CNCM I-3856
Experimental
干预措施: Saccharomyces cerevisiae CNCM I-3856 (Dietary Supplement)
结局指标
主要结局
Change from baseline in discomfort score,obtained by Daily Likert Scale averaged by week
时间窗: baseline and week 8
次要结局
未报告次要终点
研究者
研究点 (1)
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