Microbiome-targeted Diet Therapy in Ulcerative Colitis

September 10, 2026 updated by: University of Minnesota
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
          • Levi Teigen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: On-Off Cycling Intervention

1 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
Other: High Protein, High Fiber (HPHF) Diet
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal H2S Production
Time Frame: Week 4
Assessed from stool samples
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Levi Teigen, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 26, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GI-2026-34620

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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