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DRIVE-UP: Vancomycin in Ulcerative Colitis and Primary Sclerosing Cholangitis
NCT07341282Phase 2
Key facts
- Status
- Recruiting
- Start
- Jun 2026
- Primary completion
- Dec 2027
- Countries
- 1
- Sponsor
- McMaster University
- Modality
- Cyclic Peptides, Antimicrobial Peptides, Small Molecules
- Drugs
- vancomycin
- Conditions
- ulcerative colitis (UC)
01
Overview
Phase 2, randomised, double-blind trial in ulcerative colitis (UC) comparing Placebo Comparator with Vancomycin (2 arms). Primary endpoints: Recruitment rate at 12 months, Retention rate at 12 months and 2 more. Started Jun 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo Comparator
4 weeks blinded placebo followed by optional 4 weeks open-label vancomycin.
Vancomycin
4 weeks blinded oral vancomycin followed by optional additional 4 weeks open-label vancomycin.
03
Who it enrols
Adults with co-existing moderate to severe ulcerative colitis and primary sclerosing cholangitis, excluding those with Crohn's, decompensated liver disease, severe renal impairment, or recent antibiotic/probiotic use.
04
Endpoints
Primary
Recruitment rate
Retention rate
Treatment adherence
Protocol compliance with study procedures
Secondary
Incidence of adverse events and serious adverse events
Severity and type of adverse events
Relationship of adverse events to oral vancomycin
Patient-reported tolerability of oral vancomycin
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