Poop pills plus biologics: a new hope for ulcerative colitis?
NCT ID NCT05327790
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University of Alberta Hospital
RECRUITINGEdmonton, Alberta, T6G 2X8, Canada
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