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

Recruiting now · Not applicable

Conditions studied: Crohn's Disease in Remission

In brief

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.

Key facts

Study ID: NCT05849012
Run by: University of Michigan
People needed: 20
Starts: 2023-12-12
Expected to finish: 2027-04-30
Last updated by the study team: 2026-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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.

Where it is running

University of Michigan — Ann Arbor, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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