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Poop pills plus biologics: a new hope for ulcerative colitis?

NCT ID NCT05327790

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether adding a freeze-dried fecal microbiota transplant (FMT) to standard biologic drugs (vedolizumab or ustekinumab) helps people with ulcerative colitis reach remission more safely and effectively. About 40 adults with active UC will receive either FMT or a placebo alongside their biologic. The study focuses on safety and remission rates over 24 weeks.

What this could mean

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

Active substance
Fecal microbiota transplant (FMT) combined with vedolizumab or ustekinumab
What this could lead to
If it works, this could point toward a safer, more effective way to induce remission in ulcerative colitis by combining gut bacteria therapy with standard biologics.
What could go wrong
This is a small, early-phase pilot trial with only 40 participants. The added benefit of FMT over biologics alone is unproven, and there are risks of infection or worsening colitis.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

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

Started

Jun 2022

Expected to finish

Mar 2027

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: 1. 18 years of age or older but less than 75 years of age 2. Able to provide informed consent 3. Established ulcerative colitis diagnosis determined by a physician through standard endoscopic and histologic criteria 4. Active UC defined as total Mayo score between 6-12 AND Mayo endoscopic sub-score \>1 with disease that extends 15 cm or more from the anal verge 5. Selected by treating physician for initiation of biologic treatment with either vedolizumab or ustekinumab. Patients must be: * Biologic naive; OR * Have failed anti-TNF, anti-integrin, anti IL12/23 or oral small molecules 6. Use of effective contraception method for women of childbearing potential for at least 4 weeks prior to receiving study treatment and for the duration of the trial 7. Willing and able to comply with all required study procedures Exclusion Criteria: 1. Severe UC requiring hospitalization 2. Indeterminate colitis 3. Evidence of or treatment for C difficile infection or other intestinal pathogen, including CMV, within 4 weeks prior to enrollment 4. Evidence of toxic megacolon or gastrointestinal perforation on imaging 5. Abdominal surgery within the past 60 days * Neutropenia with absolute neutrophil count \<0.5 x 109/L * Peripheral white blood cell count \> 35.0 x 109/L and fever (\>38 degrees Celsius) * Planned or actively taking another investigational product * Uncontrolled medical conditions such as psychiatric disorders or substance abuse * Severe underlying disease such that the patient is not expected to survive for at least 30 days 6. Pregnant or lactating 7. Unwilling to discontinue non-dietary probiotic 8. Antibiotic use in the past 30 days or anticipated need for systemic antibiotic use during study 9. FMT within 3 months prior to enrollment 10. Use of the following medications: 1. rectal/topical therapy within 2 weeks of screening 2. cyclosporine, tacrolimus or thalidomide within 4 weeks of screening 3. tofacitinib within 4 weeks of screening 4. adalimumab or infliximab within 8 weeks of screening 5. vedolizumab within 8 weeks of screening 6. ustekinumab within 12 weeks of screening 7. prednisone \> 30 mg/d 11. Investigator deems enrolment in the study is not in the best interest of the patient

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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 Alberta Hospital

    RECRUITING

    Edmonton, Alberta, T6G 2X8, Canada

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