NCT04640155

Treating Chronic Pouchitis With a Low FODMAP Diet

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pouchitis

Interventions

Type	Name	Description
BEHAVIORAL	Low FODMAP Diet	Patients in the low FODMAP group will schedule a telephone visit with a registered dietician. During this approximately hour-long session, patients in the low FODMAP cohort will be counselled regarding FODMAP containing foods and how to effectively remove them while maintaining a nutrition-rich diet.
BEHAVIORAL	Regular Diet	Patients in the regular diet group will receive an educational handout discussing low fiber diet, which is standard of care for those with pouchitis symptoms.

Timeline

• Start date: 2020-10-27
• Primary completion: 2022-10-27
• Completion: 2022-10-27
• First posted: 2020-11-23
• Last updated: 2023-02-13

Locations

1 site across 1 country: United States