Microbiome-targeted Diet Therapy in Ulcerative Colitis

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Fecal H2S Production

Time frame: Week 4

Assessed from stool samples

Study contacts

Contact information is provided by the study sponsor or research team.

Lulu Chen

CONTACT

[email protected]

612-301-8294

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Apr 9, 2026
Registry last updated: Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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