Treating Chronic Pouchitis With a Low FODMAP Diet

Not Applicable

Withdrawn

• Conditions: Pouchitis
• Interventions: Behavioral: Low FODMAP Diet; Behavioral: Regular Diet

• Registration Number: NCT04640155
• Lead Sponsor: Northwestern University

Brief Summary

We aim to determine whether low FODMAP diet in patients with chronic pouchitis will improve symptoms and pouch inflammation.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-10-27
• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-11-17
• Study First Posted: 2020-11-23
• Primary Completion: 2022-10-27
• Study Completion: 2022-10-27
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low FODMAP	Low FODMAP Diet	-
Regular Diet	Regular Diet	-

Primary Outcome Measures

Name	Time	Method
Mean Difference in Fecal Calprotectin	6 weeks

Secondary Outcome Measures

Name	Time	Method
Mean Difference in Cleveland Global Quality of Life Score	6 weeks
Mean Difference in Composite Symptom Scores	6 weeks	Composite symptom score will include both clinical portion of Pouchitis Disease Activity Index as well as Oresland score, with possible scores ranging from 0-21 (higher number indicates higher symptom burden)
Rate of Normalization of Fecal Calprotectin	6 weeks

Trial Locations

Locations (1)

Northwestern Medicine Digestive Health Center; 🇺🇸 Chicago, Illinois, United States