Investigation of Vancomycin Efficacy in Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis
Phase 2 · Testing Vancomycin (blinded) and Vancomycin (open-label extension) · 1 site · McMaster University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Vancomycin (blinded) (a drug) and Vancomycin (open-label extension) (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC) and Primary Sclerosing Cholangitis (PSC).
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 7 more requirement(s). Only the trial team can confirm whether you qualify.
What's involved
- About 14 participants are expected to take part.
- The study has 2 groups.
- Start date: 2026-06-17.
- Main results expected around 2027-12 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Canada.
Groups in this study
- Placebo Comparator (listed as: placebo group)
- Vancomycin (listed as: experimental group)
Main thing being measured
- Recruitment rate (12 months)
- Retention rate (12 months)
- Treatment adherence (12 months)
In the researchers’ words
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…
Words you might see
- Decompensated liver disease: advanced liver disease with complications such as fluid build-up or bleeding.
- Placebo: a look-alike pill or injection with no active drug, used for comparison.
- Open-label: everyone, including participants, knows which treatment is being given.
- Endoscopy: a camera exam inside the digestive tract.
- Mayo score: a score used to measure how active ulcerative colitis is.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC); Primary Sclerosing Cholangitis (PSC) |
| Lead sponsor | McMaster University |
| Collaborators | Weston Family Foundation |
| Enrollment | 14 (estimated) |
| Start date | 2026-06-17 |
| Primary completion (est.) | 2027-12 |
| First posted | 2026-01-14 |
| Last updated | 2026-10-09 |
| Official title | Investigation of Vancomycin Efficacy in Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis |
| ClinicalTrials.gov ID | NCT07341282 |
Interventions
- Placebo (blinded) (Drug)
Identical placebo capsule administered orally twice daily for 4 weeks. - Vancomycin (blinded) (Drug)
Vancomycin 250 mg administered orally twice daily for 4 weeks. - Vancomycin (open-label extension) (Drug)
Vancomycin 250 mg administered orally twice daily for 4 weeks (optional extension offered to both arms).
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| McMaster Children's Hospital - Digestive Diseases Clinic | Hamilton, Ontario | Canada | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.