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A Pilot Study Examining Low Sulfur Diet as Treatment for Persistent Symptoms in Quiescent Crohn's Disease
Who can join
Ages 18 and older · All sexes
Full 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 * Patients who are underweight as defined by BMI \< 18.5 kg/m2 or have significant unintentional weight loss as defined by \>7.5% body weight in the past 3 months * Currently pregnant, breastfeeding, and/or unwillingness/inability to use contraception start of the study until the last 13C-mannitol:lactulose test is complete. Sexually active male participants and/or their female partners of reproductive potential must agree to use effective contraception from the start of the study and until the last 13C-mannitol:lactulose test is complete. Women who are breastfeeding must stop breastfeeding during and for at least 12 hours after consuming the 13C-mannitol:lactulose test. Breastfeeding women must pump and dispose of the breastmilk during this time period * Subjects must agree to not donate sperm or ova (eggs) or breast milk from the start of the study until the last 13C-mannitol:lactulose test is complete.
About the study
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.
What is being tested
- Low Sulfur Diet (other)
- Usual Diet (other)
Sponsor: University of Michigan · Participants: 20 · Started: Dec 12, 2023
Contact the study team
- Allen Lee, MD, MS · Phone: 734-936-9454
Official record on ClinicalTrials.gov — NCT05849012
Locations in the U.S.
| Michigan | University of Michigan, Ann Arbor |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.