NCT02614963Unknown4 期
Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome: A Randomized, Double-blinded,Placebo- Controlled Multicenter Study
Shandong University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- the changes of Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) scores
研究概览
简要总结
Clostridium Butyricum might be an effective drug in treating irritable bowel syndrome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •the presence of Rome III criteria for IBS ;
- •Aged between 18 and 65 years old
排除标准
- •Antibiotic, probiotic or laxative usage within 4 weeks.
- •organic gastrointestinal diseases
- •Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc.
- •pregnancy or lactation.
- •previous major or complicated abdominal surgery.
- •severe endometriosis and dementia
研究组 & 干预措施
Clostridium Butyricum group
Experimental
Irritable bowel syndrome patients treated with Clostridium Butyricum
干预措施: Clostridium Butyricum (Drug)
Placebo group
Placebo Comparator
Irritable bowel syndrome patients treated with placebo
干预措施: placebo (Drug)
结局指标
主要结局
the changes of Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) scores
时间窗: 7 months
次要结局
- IBS patients'quality of life(7 months)
- Composition of Microorganisms in stool(7 months)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University
研究点 (1)
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