A Pilot Study Examining Low Sulfur Diet as Treatment for Persistent Symptoms in Quiescent Crohn's Disease
Recruiting · NCT05849012 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Michigan
View the official record on ClinicalTrials.gov →Interventions studied
Low Sulfur DietUsual Diet
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- University of Michigan - Ann Arbor, Michigan, United States