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Recruiting NCT05849012

A Pilot Study Examining Low Sulfur Diet as Treatment for Persistent Symptoms in Quiescent Crohn's Disease

Trial Parameters

Condition Crohn's Disease in Remission
Sponsor University of Michigan
Study Type INTERVENTIONAL
Phase N/A
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-12-12
Completion 2026-12-30
Interventions
Low Sulfur DietUsual Diet

Brief Summary

The goal of this study is to learn about a low sulfur diet in patients with Crohn's disease. Study participants will be randomized to receive a low sulfur diet or usual diet for 8 weeks. Participants will work with study nutritionists and receive dietary educational materials. Participants will attend 2 in-person visits as well as 6 phone visits during the study. In addition, subjects will undergo testing, including a test to measure rectal sensation, a test to look for small intestinal bacterial overgrowth, and a test to measure leaky gut.

Eligibility Criteria

Inclusion Criteria: * Prior diagnosis of Crohn's disease based on endoscopic, radiographic, and/or histologic findings * Quiescent Crohn's disease as defined by fecal calprotectin level less than 150 micrograms/gram (mcg/g) stool and/or absence of inflammation on colonoscopy within 30 and 90 days, respectively, of enrollment * Persistent symptoms will be defined by abdominal pain and/or diarrhea T-scores greater than or equal to 55 by the National Institutes of Health (NIH) Patient-Reported outcomes measurement information system Gastrointestinal scale (PROMIS-GI) Exclusion Criteria: * Prior total colectomy * Presence of an end ileostomy or colostomy in place * Changes in immunosuppressive medications within the past 4 weeks * Use of antibiotics or probiotics within the past 4 weeks * Active or suspected stricture/stenosis of the GI tract * Habitual vegetarian or vegan diet * Active or suspected gastrointestinal stricture or stenosis * Unable or unwilling to follow a low sulfur diet *

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