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NCT07520461
Microbiome-targeted Diet Therapy in Ulcerative Colitis
Conditions: Ulcerative Colitis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: University of Minnesota
Location: University Of Minnesota Minneapolis Minnesota
Summary
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
Source: ClinicalTrials.gov (NCT07520461). StuddyBuddy aggregates publicly available trial information.