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Old antibiotic, new hope? vancomycin trial for UC and PSC

NCT ID NCT07341282

Disease control Sponsor: McMaster University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 pilot study tests whether the antibiotic vancomycin can safely treat active ulcerative colitis in adults who also have primary sclerosing cholangitis, a liver condition. Fourteen participants will take vancomycin or a placebo for 4 weeks, with an optional 4-week extension. The main goal is to see if the study is feasible, while also checking for safety and early signs of benefit.

What this could mean

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

Active substance
vancomycin
What this could lead to
If it works, this could point toward a new treatment option for people with both ulcerative colitis and primary sclerosing cholangitis.
What could go wrong
This is a very small pilot study with only 14 participants, focused on feasibility. It is too early to know if vancomycin will actually improve symptoms or be safe long-term.

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 14 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

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 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 * Adults aged ≥18 years. * Confirmed diagnosis of UC and PSC. * Moderate to severe UC disease activity (total Mayo score ≥5; endoscopic subscore ≥2). * Informed consent provided. Exclusion Criteria * Diagnosis of Crohn's disease or indeterminate colitis. * Fulminant colitis or need for immediate surgical intervention. * Use of antibiotics or probiotics within the past 4 weeks (for microbiome substudy). * Decompensated liver disease (Child-Pugh B/C). * Severe Renal Impairment (CrCl \<30mL/min) * Active untreated infection. * Pregnancy or lactation. * Prior allergy or intolerance to Vancomycin * History of hearing loss or current hearing problems

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Conditions

The condition(s) this trial relates to.

Cholangitis, Sclerosing primary sclerosing cholangitis ulcerative colitis

As listed by the trial registrant

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

Primary sclerosing cholangitis (PSC) Ulcerative colitis (UC)

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

  • McMaster Children's Hospital - Digestive Diseases Clinic

    Hamilton, Ontario, L8N 3Z5, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.