NCT07341282RecruitingPhase 2
Investigation of Vancomycin Efficacy in Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 2 Dec 2025
- Start date
- 17 Jun 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- McMaster University
- Diseases
- Ulcerative colitis
- NCT number
- NCT07341282
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 14
- From 17 Jun 2026 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McMaster Children's Hospital - Digestive Diseases Clinic Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.