Examining a low sulfur diet for treating persistent symptoms in Crohn's disease
A Pilot Study Examining Low Sulfur Diet as Treatment for Persistent Symptoms in Quiescent Crohn's Disease
This study tests if a low sulfur diet can help people with Crohn's disease who still have symptoms feel better after 8 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05849012 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a low sulfur diet on patients with quiescent Crohn's disease who experience persistent symptoms. Participants will be randomly assigned to either a low sulfur diet or their usual diet for a duration of 8 weeks. Throughout the study, participants will receive support from nutritionists and undergo various tests to assess gut health and symptom relief. The aim is to explore how dietary changes may influence the gut microbiome and alleviate ongoing symptoms in these patients.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with quiescent Crohn's disease who experience persistent gastrointestinal symptoms.
Not a fit: Patients who have undergone total colectomy or have an ileostomy or colostomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a dietary intervention that significantly improves the quality of life for patients with persistent symptoms of Crohn's disease.
How similar studies have performed: While dietary interventions in Crohn's disease are being explored, this specific low sulfur diet approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Allen Lee, MD, MS — Assistant Professor
- Study coordinator: Allen Lee, MD, MS
- Email: allenlee@umich.edu
- Phone: 734-936-9454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.