Microbiome-targeted Diet Therapy in Ulcerative Colitis
Not applicable · Testing High Protein, High Fiber (HPHF) Diet · 1 site · University of Minnesota
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing High Protein, High Fiber (HPHF) Diet as a possible treatment. Condition(s) listed: Ulcerative Colitis.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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).
Plus 4 more requirement(s). There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- The study has 1 group.
- Start date: 2026-10-15 (planned).
- Main results expected around 2029-06-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Groups in this study
- On-Off Cycling Intervention (listed as: experimental group)
Main thing being measured
- Fecal H2S Production (Week 4)
In the researchers’ words
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.
Words you might see
- Endoscopy: a camera exam inside the digestive tract.
- Biologic: a medicine made from living cells, usually given by injection or infusion.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | University of Minnesota |
| Enrollment | 40 (estimated) |
| Start date | 2026-10-15 |
| Primary completion (est.) | 2029-06-01 |
| First posted | 2026-04-09 |
| Last updated | 2026-10-06 |
| Official title | Microbiome-targeted Diet Therapy in Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT07520461 |
Interventions
- High Protein, High Fiber (HPHF) Diet (Other)
The HPHF diet is a diet designed to maximize the intake of proteins and fermentable dietary fibers. Frozen meals are provided to participants weekly and consumed over two non-consecutive 7-day periods.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Minnesota | Minneapolis, Minnesota | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.