NCT05849012Recruiting
A Pilot Study Examining Low Sulfur Diet as Treatment for Persistent Symptoms in Quiescent Crohn's Disease
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 25 Apr 2023
- Start date
- 12 Dec 2023
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- University of Michigan
- Diseases
- Crohn's disease
- NCT number
- NCT05849012
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 12 Dec 2023 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior total colectomy
- Changes in immunosuppressive medications within the past 4 weeks
Other
- Presence of an end ileostomy or colostomy in place
- 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.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.