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Could a High-Protein, High-Fiber diet tame ulcerative colitis?

NCT ID NCT07520461

Disease control Sponsor: University of Minnesota Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 15, 2026 · Updated 7 times

Summary

This study will test whether a diet rich in protein and fiber can reduce harmful gas-producing bacteria in the gut of people with ulcerative colitis. Forty adults with mild to moderate disease will eat specially prepared frozen meals for two separate week-long periods. Researchers will measure changes in gut bacteria and hydrogen sulfide levels from stool samples.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
High Protein, High Fiber (HPHF) Diet
What this could lead to
If successful, this diet could offer a new way to manage ulcerative colitis by reducing harmful gut bacteria and improving symptoms.
What could go wrong
This is a small, early-stage trial with only 40 people. The diet may be hard to follow long-term, and it's not yet known if it will actually improve disease outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

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