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Investigation of Vancomycin Efficacy in Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis

Study acronym: DRIVE-UP
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2026 → Dec 2027
See other at-risk trials from McMaster University

Record History

  1. Primary completion pushed from Dec 2026 to Dec 2027 Recruitment opened · Start date changed from estimate of Jan 2026 to Jun 17, 2026 · Completion pushed from Mar 2027 to Dec 2027 · 5 more Show 8 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Jan 2026 to Jun 17, 2026
    • Completion pushed from Mar 2027 to Dec 2027
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Study description expanded, about 22 words
    • Site details revised
    • Publications: details revised at 9 of 9 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07341282
Lead Sponsor McMaster University
Collaborators: Weston Family Foundation
Conditions Ulcerative Colitis (UC), Primary Sclerosing Cholangitis (PSC)
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov