Oral vancomycin for ulcerative colitis in people who also have primary sclerosing cholangitis
Tests oral vancomycin against placebo in adults with ulcerative colitis and primary sclerosing cholangitis.
Plain-language title generated from the registry record
Registry title: Investigation of Vancomycin Efficacy in Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis
Key facts
- Where
- Hamilton, CanadaSee the site
- Phase
- Phase 2
Where in Canada
- McMaster Children's Hospital - Digestive Diseases ClinicHamilton, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- McMaster University
- Trial code
- NCT07341282
- Record updated
- 9 October 2026
- Original description
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:Read full original descriptionShow less
Investigation of Vancomycin Efficacy in Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis
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.
Inclusion: 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.