NCT02249169已完成不适用
Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in gut microbiome in patients with IBS compared to healthy individuals measured over 6 months
研究概览
简要总结
This longitudinal study is being done to understand mechanisms underlying development of irritable bowel syndrome (IBS) and the role of the gut bacteria in development of symptoms. This information will be used to determine whether temporal changes in gut microbial taxonomy and metabolism are associated with changes in symptom severity in IBS, and if targeted dietary interventions, including prebiotics, can reverse or moderate these changes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 是
入选标准
- •Clinical diagnosis of IBS-C or IBS-D
- •Age 18 to 65
排除标准
- •Prior history of abdominal surgeries (except appendectomy and cholecystectomy)
- •Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory condition
- •Antibiotic use within the past 4 weeks (they can be enrolled after a four-week washout period and subsequent use during the 6-month study duration does not exclude them)
- •Bleeding risk or medications which may increase risk of bleeding for patients who agree to undergo flexible sigmoidoscopy
- •Bowel preparation for colonoscopy within the past week
- •Pregnancy or plans to become pregnant within the study time frame
- •Vulnerable adults
- •Age greater than or equal to 66
- •Any other disease(s), condition(s) or habit(s) that would interfere with completion of the study, would increase risks of flexible sigmoidoscopy (for those opting for this), or in the judgment of the investigator would potentially interfere compliance to this study or would adversely affect study outcomes
- •HEALTHY SUBJECTS:
- •Inclusion Criteria:
- •Age 18 to 65
- •No clinical diagnosis of IBS-C or IBS-D
- •Exclusion Criteria:
- •Prior history of abdominal surgeries (except appendectomy and cholecystectomy)
- •Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory condition
- •Antibiotic use within the past 4 weeks (they can be enrolled after a four-week washout period and subsequent use during the 6-month study duration does not exclude them)
- •Bleeding risk or medications which may increase risk of bleeding for patients who agree to undergo flexible sigmoidoscopy
- •Bowel preparation for colonoscopy within the past week
- •Pregnancy or plans to become pregnant within the study time frame
- •Vulnerable adults
- •Age greater than or equal to 66
- •Any other disease(s), condition(s) or habit(s) that would interfere with completion of the study, would increase risks of flexible sigmoidoscopy (for those opting for this), or in the judgment of the investigator would potentially interfere compliance to this study or would adversely affect study outcomes
- •Clinical diagnosis of IBS-C or IBS-D
结局指标
主要结局
Change in gut microbiome in patients with IBS compared to healthy individuals measured over 6 months
时间窗: baseline, 6 months
Participants will provide a stool sample at baseline and at periodic intervals for 6 months to assess gut microbial composition.
次要结局
未报告次要终点
研究者
研究点 (1)
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