Investigation of Vancomycin Efficacy in Patients With Ulcerative Colitis and Primary Sclerosing C… (NCT07341282) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Investigation of Vancomycin Efficacy in Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis
Canada14 participantsStarted 2026-01
Plain-language summary
This clinical trial tests if oral vancomycin can safely treat active ulcerative colitis (UC) in adults who also have primary sclerosing cholangitis (PSC), a liver condition. The main questions it aims to answer are:
* Can oral vancomycin improve UC symptoms as measured by Mayo score at 4 weeks?
* Is oral vancomycin safe and tolerable in this patient group?
Participants will be compared to see if vancomycin works better than placebo. Participants will:
* Take oral vancomycin (250 mg twice daily) or identical placebo capsules for 4 weeks
* Have the option for 4 more weeks of open-label vancomycin after the blinded phase
* Attend clinic visits at baseline, week 4, and follow-up for Mayo scoring, endoscopy, blood/stool tests, and safety checks
* Track treatment adherence and side effects
The study primarily assesses if the trial can recruit 14 participants, retain them, achieve good adherence, and follow protocol procedures (feasibility). Secondary goals include safety (adverse events) and early signs of benefit in UC activity, liver tests, and gut bacteria balance. This pilot will guide larger future studies.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.