NCT07520461Recruiting
Microbiome-targeted Diet Therapy in Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
The central objective of this proposal is to test a novel diet capable of meeting the elevated protein requirements in ulcerative colitis (UC), while simultaneously decreasing microbial hydrogen sulfide (H2S) production in the colon with fiber.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 2 Apr 2026
- Start date
- 9 Nov 2026
- Primary completion date
- 1 Jun 2029
- Lead sponsor
- University of Minnesota
- Diseases
- Ulcerative colitis
- NCT number
- NCT07520461
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 9 Nov 2026 to the primary completion date, 1 Jun 2029
- 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
- Ongoing alcohol or drug abuse
Other illness
- History of stomach surgery or bowel resection
- History of anaphylactic food allergies
Other
- Moderate or severe UC as defined by UCEIS ≥5
- Antibiotic use within 3 months
- Anticipated antibiotic exposure during the study period (e.g. perioperative antibiotics)
- Pregnancy or breastfeeding
- Intolerance of high dietary fiber content
- Habitual vegan diet pattern
- Insufficient freezer space to accommodate meal delivery
Who the study is looking for
- Ability and willingness to provide informed consent
- Age at least 18 years old
- Diagnosis of UC based on clinical and endoscopic criteria
- UC duration of at least 3 months
- Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score ≤4 within 90 days of randomization
- On a stable dose or no existing UC therapies (apart from steroids) for defined periods (as outlined below).
- ≥4 weeks if no medication, 5-ASA
- ≥8 wk for immunomodulatory therapy
- ≥12 wk for biologics
- Ability to comply with study requirements in the opinion of the primary investigator
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 Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.