Vancomycin (open-label extension): Vancomycin 250 mg administered orally twice daily for 4 weeks (optional extension offered to both arms).
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Recruitment rate — 12 months Proportion of eligible participants who provide consent and are enrolled in the study (number enrolled ÷ number eligible approached), with a target of 14 participants within 12 months.
Retention rate — 12 months Proportion of enrolled participants who complete all protocol-specified study visits and assessments at 12 months (number completing all follow-up visits ÷ number enrolled).
Treatment adherence — 12 months Proportion of prescribed oral vancomycin doses taken over the treatment period, assessed by pill counts and/or medication diary (number of doses taken ÷ number of doses prescribed).
Protocol compliance with study procedures — 12 months Proportion of participants with all required visits, laboratory tests, and assessments completed per protocol (number fully compliant ÷ number enrolled); may also include rate of major protocol deviations.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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