Using broccoli sprouts to help manage mild ulcerative colitis
A Pilot Feasibility Study to Develop a Broccoli Sprouts-enriched Diet in the Management of Ulcerative Colitis
This study tests if eating broccoli sprouts can help people with mild ulcerative colitis feel better by lowering inflammation in their bodies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05507931 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of broccoli sprouts in increasing sulforaphane levels and reducing inflammatory markers in patients with mild ulcerative colitis. Participants will consume either one or three servings of broccoli sprouts, and the study will measure changes in their stool and blood. This pilot feasibility study is designed to gather preliminary data to inform a larger randomized controlled trial in the future.
Who should consider this trial
Good fit: Ideal candidates are adults with a documented diagnosis of mild ulcerative colitis who are stable on their current medication regimen.
Not a fit: Patients with severe ulcerative colitis or those on non-steroidal anti-inflammatory drugs (NSAIDs) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a dietary intervention that helps reduce inflammation and improve symptoms in patients with mild ulcerative colitis.
How similar studies have performed: While this approach is novel, previous studies have suggested potential benefits of dietary interventions in inflammatory bowel disease, though specific outcomes with broccoli sprouts are less established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Documented endoscopic diagnosis of ulcerative colitis * Currently being treated with a stable dose of 5-ASAs, steroids, or any other medication approved for ulcerative colitis * If on 5-ASA, no dose changes within 2 weeks before the Day 0 visit * If on steroids, prednisone dose not more than 20 mg daily and entocort not more than 9 mg daily, with no dose changes within 2 weeks before the Day 0 visit * All other medications require a stable dose for at least 8 weeks prior to enrollment. * No dose changes to any IBD medication anticipated for the duration of the study * Body Mass Index (BMI) values 18.5-40 kg/m2 * Not on total parenteral nutrition (TPN) or receiving tube feeds. * Ability to understand the study procedures, benefits and risks, and sign a written informed consent document. * Able to fill out questionnaires regarding dietary intakes, bowel symptoms, and study experience Exclusion Criteria: * Taking Non-steroidal anti-inflammatory drugs (NSAIDs) * Following a medically-prescribed diet, on Total parenteral nutrition (TPN), or tube feeds * Newly diagnosed (within past month), or uncontrolled diabetes or cardiovascular disease * Antibiotics in the previous 2 weeks * Consumption of more than 5 ½ cups of servings/day of fruits and vegetables as assessed by the National Cancer Institute (NCI) Diet History Questionaire III online Food Questionnaire. * A known allergy or sensitivity to cruciferous vegetables like arugula, bok choy, broccoli, cabbage, cauliflower, or collard greens
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Grace Chen — University of Michigan
- Study coordinator: Kelli Porzondek
- Email: kporzond@med.umich.edu
- Phone: 734-764-0507
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.