Therapeutic Effects of Pectin Supplementation in Patients With Diarrhea-predominant Irritable Bowel Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 主要终点
- efficacy: change of stool frequency, faecal form and clinical symptoms score
研究概览
简要总结
The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary fiber, on clinical symptoms, gut microbiota and the immune status in patients with diarrhea-predominant irritable bowel syndrome
详细描述
Patients were randomized to receive either pectin or placebo. Treatment consisted of 6 weeks supplementation with pectin (fiber group) or placebo (maltodextrin). We evaluated the clinical symptoms, gut microbiota and the immune markers in two groups.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients(age≧18y)
- •Admitted for diarrhea-predominant irritable bowel syndrome
排除标准
- •Mental disorders
- •Inflammatory bowel disease
结局指标
主要结局
efficacy: change of stool frequency, faecal form and clinical symptoms score
时间窗: six weeks after inclusion
change from baseline in stool frequency, faecal form (Bristol stool scale) and clinical symptoms score (7-point Likert scale) at six weeks
次要结局
- efficacy: gut microbiota(six weeks after inclusion)
- efficacy: cytokine ratios(six weeks after inclusion)
研究者
Gao Tao
Nanjing PLA General Hospital
Nanjing PLA General Hospital