Microbiome-targeted Diet Therapy in Ulcerative Colitis
Recruiting · NCT07520461 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
High Protein, High Fiber (HPHF) Diet
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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).
- ≥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
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
Where it is running
1 location listed across 1 US state.
- University Of Minnesota - Minneapolis, Minnesota, United States