Phase
Condition
N/ATreatment
Usual Diet
Low Sulfur Diet
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Prior diagnosis of Crohn's disease based on endoscopic, radiographic, and/orhistologic findings
Quiescent Crohn's disease as defined by fecal calprotectin level less than 150micrograms/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-scoresgreater than or equal to 55 by the National Institutes of Health (NIH)Patient-Reported outcomes measurement information system Gastrointestinal scale (PROMIS-GI)
Exclusion
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 significantunintentional weight loss as defined by >7.5% body weight in the past 3 months
Currently pregnant, breastfeeding, and/or unwillingness/inability to usecontraception start of the study until the last 13C-mannitol:lactulose test iscomplete. Sexually active male participants and/or their female partners ofreproductive potential must agree to use effective contraception from the start ofthe study and until the last 13C-mannitol:lactulose test is complete. Women who arebreastfeeding must stop breastfeeding during and for at least 12 hours afterconsuming the 13C-mannitol:lactulose test. Breastfeeding women must pump and disposeof the breastmilk during this time period
Subjects must agree to not donate sperm or ova (eggs) or breast milk from the startof the study until the last 13C-mannitol:lactulose test is complete.
Study Design
Study Description
Connect with a study center
University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
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