Effects of Pectin Supplementation in Diarrhea-predominant Irritable Bowel Syndrome
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Nanjing PLA General Hospital
临床试验: NCT02270268
BioSeek: NCT02270268
关键词
抽象
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
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.
日期
| 最后验证: | 02/29/2016 |
| 首次提交: | 10/09/2014 |
| 提交的预估入学人数: | 10/16/2014 |
| 首次发布: | 10/20/2014 |
| 上次提交的更新: | 03/22/2016 |
| 最近更新发布: | 03/23/2016 |
| 实际学习开始日期: | 10/31/2011 |
| 预计主要完成日期: | 09/30/2013 |
| 预计完成日期: | 09/30/2013 |
状况或疾病
Irritable Bowel Syndrome
干预/治疗
Dietary Supplement: pectin
Dietary Supplement: Placebo
相
相 3
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: pectin a kind of soluble dietary fiber | Dietary Supplement: pectin Pectin （Andeli Ltd. Yantai, China）, 24g/d for six weeks |
| Placebo Comparator: Placebo maltodextrin | Dietary Supplement: Placebo |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - All patients(age≧18y) - Admitted for diarrhea-predominant irritable bowel syndrome Exclusion Criteria: - Mental disorders - Cancer - Inflammatory bowel disease |
结果
主要结果指标
1. efficacy: change of stool frequency, faecal form and clinical symptoms score [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
次要成果指标
1. efficacy: gut microbiota [six weeks after inclusion]
real-time PCR
2. efficacy: cytokine ratios [six weeks after inclusion]
Cytokine production
