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

RecruitingPhase 2Ages 18 Years - anyAllMcMaster University
NCT07341282 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 adhe

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📋 Eligibility rules (as published)
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
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What it tests

  • Placebo (blinded)
  • Vancomycin (blinded)
  • Vancomycin (open-label extension)
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Where

1 site
McMaster Children's Hospital - Digestive Diseases Clinic
Hamilton, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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