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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Allen Lee, MD, MS
allenlee@umich.edu
734-936-9454
Backup
Michael Santiago-Castro
santiamn@med.umich.edu
Time Frame
Start Date: 2023-12-12
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 20
Treatments
Experimental: Low Sulfur Diet
Participants in this group will follow a low sulfur diet. This diet decreases the amount of animal products (including meat, dairy, and eggs) as well as sulfur additives in the diet. The main types of foods in the low sulfur diet include fruits, vegetables, whole grains, nuts, seeds, and soy products.
Active_comparator: Usual Diet
Participants in this group will follow a standard of care usual diet for 8 weeks.
Sponsors
Leads: University of Michigan

This content was sourced from clinicaltrials.gov