Microbiome-targeted Diet Therapy in Ulcerative Colitis
Starting soon · Not applicable
Conditions studied: Ulcerative Colitis
In brief
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.
Key facts
- Study ID
- NCT07520461
- Run by
- University of Minnesota
- People needed
- 40
- Starts
- 2026-09-07
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Moderate or severe UC as defined by UCEIS ≥5
- History of stomach surgery or bowel resection
- Antibiotic use within 3 months
- Anticipated antibiotic exposure during the study period (e.g. perioperative antibiotics)
- Pregnancy or breastfeeding
- History of anaphylactic food allergies
- Intolerance of high dietary fiber content
- Ongoing alcohol or drug abuse
- Habitual vegan diet pattern
- Insufficient freezer space to accommodate meal delivery
Full record on ClinicalTrials.gov
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