Vancomycin for active ulcerative colitis with primary sclerosing cholangitis
Official title: Investigation of Vancomycin Efficacy in Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis
Run by McMaster University · NCT07341282 · Data updated 2026-11-12
This study tests whether oral vancomycin can help adults with both ulcerative colitis and primary sclerosing cholangitis more than a placebo over four weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 14 (estimated) |
| Sponsor | McMaster University Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Status | Recruiting |
| Started | June 17, 2026 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT07341282 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with confirmed ulcerative colitis and primary sclerosing cholangitis, moderate to severe UC activity, and no exclusion criteria preventing study participation.
✕Probably not a fit
Patients with alternate diagnoses, fulminant colitis, significant liver or kidney impairment, recent antibiotic use, or other factors that could confound results may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase 2, randomized, placebo-controlled feasibility trial evaluating oral vancomycin in adults with coexisting ulcerative colitis and primary sclerosing cholangitis. Participants receive vancomycin or placebo for 4 weeks, with an option for a subsequent open-label extension, and are assessed for treatment response using Mayo scores, endoscopy, and safety measures. The study focuses on feasibility outcomes such as recruitment, adherence, and protocol compliance, while also monitoring safety and preliminary clinical signals of benefit. Randomization is centralized and blinded, with independent oversight and predefined criteria for unblinding if clinically needed. The trial is investigator-initiated, led by McMaster University with collaboration from Weston Family Foundation, at McMaster Children's Hospital in Hamilton, Ontario.
Why it matters
Potential benefit: If successful, participants may experience improvement in UC symptoms and disease activity with a targeted microbiome approach.
How similar studies have gone: Prior studies with microbiome-targeted therapies in UC have shown variable signals; this trial explores feasibility and safety in a specific PSC-UC population, which is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
McMaster Children's Hospital - Digestive Diseases Clinic
Hamilton, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Neeraj Narula, MD — McMaster University
- Study coordinator: Neeraj Narula, MD
- Email: neeraj.narula@medportal.ca
- Phone: 905-521-2100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.