The Effects of Laxative-probiotic Sequential Treatment on the Symptoms and Fecal Microbiota in the IBS Patients.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Subject's Global Assessment of Relief
研究概览
简要总结
the laxative-probiotic sequential treatment might reduce the symptoms of IBS and alter the fecal microbiota of the patients in a more robust manner .
详细描述
Probiotics can regulate intestinal immunity, repair mucosal barrier, and reportedly exert therapeutic effects on IBS patients. The laxatives could also alter the gut microflora significantly, thus the laxative-probiotic sequential treatment might affect the symptoms and the composition of fecal microbiota in the IBS patients in a more robust manner .
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
- None
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 ;
- •Patients scheduled for colonoscopy examination or having negative screening examinations
- •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
laxative-probiotic sequential
laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks，immediately after colonoscopy
干预措施: Probiotic Clostridium Butyricum (Drug)
laxative-probiotic sequential
laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks，immediately after colonoscopy
干预措施: Laxative Polyethylene Glycol (Drug)
probiotic
Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks.
干预措施: Probiotic Clostridium Butyricum (Drug)
Laxative followed by Probiotic 2 weeks later
laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the last 2 weeks with two weeks interval after colonoscopy.
干预措施: Probiotic Clostridium Butyricum (Drug)
Laxative followed by Probiotic 2 weeks later
laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the last 2 weeks with two weeks interval after colonoscopy.
干预措施: Laxative Polyethylene Glycol (Drug)
结局指标
主要结局
Subject's Global Assessment of Relief
时间窗: 8 months
The SGA (subjective global assessment) of Relief was assessed by answering the following question: "Please consider how you felt this past week in regard to your IBS, in particular your overall wellbeing, symptoms and altered bowel habit. Compared to the way you usually felt before entering the study, how would you rate your relief of symptoms during the past week?" The scale contained five possible answers: (1) completely relieved, (2) considerably relieved, (3) somewhat relieved, (4) unchanged, or (5) worse.
次要结局
- The changes of symptom scores(8 months)
- IBS patients'quality of life(8 months)
- Composition of Microorganisms in stool(8 months)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University