Microbiome-targeted Diet Therapy in Ulcerative Colitis
1 other identifier
interventional
40
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2026
CompletedFirst Posted
Study publicly available on registry
April 9, 2026
CompletedStudy Start
First participant enrolled
July 6, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
Study Completion
Last participant's last visit for all outcomes
June 1, 2029
May 19, 2026
May 1, 2026
2.9 years
April 2, 2026
May 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Fecal H2S Production
Assessed from stool samples
Week 4
Study Arms (1)
On-Off Cycling Intervention
EXPERIMENTAL1 week standard diet, followed by 1 week high-protein, high-fiber diet, followed by 1 week standard diet, followed by 1 week high-protein, high-fiber diet
Interventions
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Levi Teigen
University of Minnesota
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2026
First Posted
April 9, 2026
Study Start (Estimated)
July 6, 2026
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
June 1, 2029
Last Updated
May 19, 2026
Record last verified: 2026-05