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临床试验/NCT04640155
NCT04640155撤回不适用

Treating Chronic Pouchitis With a Low FODMAP Diet

Northwestern University2 个研究点 分布在 1 个国家开始时间: 2020年10月27日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen Hanauer

Principal Investigator

Northwestern University

研究点 (2)

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