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Diet as medicine: could a simple food plan tame ulcerative colitis?

NCT ID NCT04121806

Disease control Sponsor: Mount Sinai Hospital, Canada 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a carefully designed diet can change the gut bacteria in people with active ulcerative colitis and reduce disease activity. Twenty adults with mild to moderate colitis will follow the diet and have their gut bacteria and inflammation levels measured. The goal is to see if food alone can help control the condition without needing stronger medications.

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 20 people

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

Started

Mar 2021

Expected to finish

Sep 2026

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 to 75 years

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: * • Females and Males between the ages of 18 - 75 years of age at the time of enrolment * Must have established diagnosis of UC by standard endoscopic, radiographic, or histological criteria * Must have active UC defined by having a Mayo score equal to or greater than 2 within two months prior to enrollment * Must have had \> 10cm involvement at some point in their disease history * FCP\>250 or active endo within 6 months * If a smoker, must not change smoking habits (frequency) during the course of the study * If receiving medical therapy, no baseline therapy change within 4 weeks of study initiation and no change during the course of the study Exclusion Criteria: * • Uncontrolled inflammation which will likely require surgery or escalation of therapy within 4 weeks of enrollment * Pregnant or lactating females * Allergy or intolerance to key or a great number food components of the study diet * Current NSAID use * Diagnosed with PSC * Using topical therapies or suppositories * Antibiotic use within 4 weeks of the study enrollment or during the study * Confirmed C. difficile infection within 3 months of recruitment; * Diagnosis of primary PSC; * Currently using topical therapies or suppositories * History of dysplasia or colorectal neoplasia.

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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.

Colitis ulcerative

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

  • Mount Sinai Hospital

    RECRUITING

    Toronto, Ontario, M5G 1X5, Canada

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