Treating Chronic Pouchitis With a Low FODMAP Diet
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Mean Difference in Fecal Calprotectin
研究概览
简要总结
We aim to determine whether low FODMAP diet in patients with chronic pouchitis will improve symptoms and pouch inflammation.
详细描述
Following recruitment for entry into the study, subjects be asked to complete symptom surveys and provide a fecal sample for calprotectin measurement. Shortly after their screening visit, patients will be randomized 1:1 to either the low FODMAP diet (experimental) or regular diet (control) group. Patients in the experimental group will schedule a telephone visit with a registered dietician. During this approximately hour-long session, patients in the low FODMAP cohort will be counseled regarding FODMAP containing foods. They will be asked to adhere to this diet over the next 6 weeks. At the end of the 6 week period, subjects will complete a 3-day food diary. Those in the regular diet group will be contacted by the dietician and given an educational handout at the beginning of the study period regarding best dietary practices. At the end of the 6 week study period, both groups will again be asked to complete another set of symptom surveys and provide a fecal sample for calprotectin measurement.
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
- Double (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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Mean Difference in Fecal Calprotectin
时间窗: 6 weeks
次要结局
- Mean Difference in Cleveland Global Quality of Life Score(6 weeks)
- Mean Difference in Composite Symptom Scores(6 weeks)
- Rate of Normalization of Fecal Calprotectin(6 weeks)
研究者
Stephen Hanauer
Principal Investigator
Northwestern University
