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Microbiome-targeted Diet Therapy in Ulcerative Colitis

NCT07520461 · University of Minnesota
In plain English

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About this study
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.
Eligibility criteria
Inclusion Criteria: * 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). 1. ≥4 weeks if no medication, 5-ASA 2. ≥8 wk for immunomodulatory therapy 3. ≥12 wk for biologics * Ability to comply with study requirements in the opinion of the primary investigator Exclusion Criteria: * 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
Study design
Enrollment target: 40 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-09-26
Estimated completion: 2029-06-01
Last updated: 2026-09-14
Interventions
Other: High Protein, High Fiber (HPHF) Diet
Primary outcomes
  • Fecal H2S Production (Week 4)
Sponsor
University of Minnesota · other
Contacts & investigators
ContactLulu Chen · contact · chen8124@umn.edu · 612-301-8294
InvestigatorLevi Teigen · principal_investigator, University of Minnesota
All locations (1)
University Of MinnesotaRecruiting
Minneapolis, Minnesota, United States