Cure8 trial brief
People with UC and PSC have limited study data on microbiome-targeted therapies; this trial asks whether short-course oral vancomycin is feasible and safe in this specific group and will look for early signals in symptoms, liver tests, and gut bacteria.
Adults with ulcerative colitis and co-existing primary sclerosing cholangitis, gastroenterologists and hepatologists involved in IBD-PSC care, clinical researchers studying microbiome-targeted therapies.
This trial is small (planned N=14) and designed to test whether it’s practical and safe to run a larger study of oral vancomycin in people who have both UC and PSC. It will look at feasibility metrics first, with safety and early biological/clinical signals as secondary aims.
The intervention is oral vancomycin 250 mg twice daily given for 4 weeks during a blinded phase, with option for 4 more weeks open-label. Assessments include endoscopic scoring (flexible sigmoidoscopy), stool and blood biomarkers, and frequent safety checks; a hepatologist will review liver safety in real time given PSC comorbidity.
If you’re thinking about the implications: this pilot can’t establish effectiveness but can inform whether a larger randomized trial is feasible and safe. It also collects microbiome and biomarker data that could guide future study design.
This is a small, single center feasibility study (planned enrollment 14) and is not designed to provide definitive evidence of benefit. Results will mainly inform safety, tolerability, recruitment, and protocol procedures for larger future trials.
Vancomycin is being studied here as a microbiome-targeted antibiotic; antibiotic effects and longer-term safety would require larger studies.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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