Investigation of Vancomycin Efficacy in Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis
NCT ID: NCT07341282
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
14 participants
INTERVENTIONAL
2026-01-31
2027-03-31
Brief Summary
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* 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.
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Detailed Description
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Randomization \& Allocation Governance
* Randomization will be implemented using validated computer-generated randomization software, with the allocation sequence generated by a study statistician not involved in clinical assessments.
* Allocation concealment will be maintained through centralized pharmacy control. An independent pharmacist will assign treatment codes and release sequentially numbered study medication containers.
* Blinding integrity will be preserved through visual and packaging equivalence, sequential drug accountability logs, and restricted access to treatment codes until database lock.
* Emergency unblinding is permitted only when required for clinical management, and all unblinding events will be documented, timestamped, and reviewed by the DSMC.
Clinical Visit \& Assessment Schedule
Participants will complete a structured study visit pathway:
* Screening (≤14 days before baseline): medical history review, infection risk screening, liver disease stability assessment, and confirmation of clinical trial eligibility documentation.
* Baseline (Week 0): clinical evaluation, safety labs, medication reconciliation, and flexible sigmoidoscopy performed by credentialed endoscopists using a standardized endoscopic scoring handbook.
* Week 2 \& 4: in-clinic evaluation, adverse event review, safety labs, and compliance verification via pill count and participant diary reconciliation.
* Week 8 (extension follow-up): final safety labs, medication reconciliation, delayed adverse event capture, and optional qualitative feasibility interview.
Adherence \& Safety Surveillance
* Participants will complete weekly digital symptom and adherence diaries capturing stool frequency, rectal bleeding trends, abdominal pain patterns, and missed doses.
* Safety labs include CBC, creatinine, liver panel, CRP, albumin, electrolytes, and will be evaluated at baseline, week 2, 4, and 8.
* A hepatologist co-investigator will review liver safety signals in real-time, given PSC-specific vulnerability to hepatic decompensation.
* Audiology risk is screened at entry, and any symptoms concerning for ototoxicity will prompt same-week clinical review.
Data Capture \& Monitoring Integrity
* All data will be captured in a secure Excel file
* Endoscopic images will be stored in a secured institutional imaging server.
* A pre-registered statistical analysis plan will be finalized before unblinding, with analysis scripts locked prior to treatment code release.
Safety Governance Structure
The DSMC will provide independent oversight and safety adjudication:
* Quarterly DSMC meetings will evaluate cumulative safety logs, recruitment feasibility, protocol deviations, and unblinding reports.
* A real-time SAE notification system ensures DSMC alert within 24 hours of serious adverse event reporting.
* Pre-defined individual, arm-level, and whole-trial safety review thresholds are codified in the DSMC governance charter to support early pause or protocol modification when required.
Regulatory \& Ethical Compliance
The trial will follow all institutional and international regulatory standards:
* ICH-GCP
* Institutional Research Ethics Board approval
* DSMC governance charter
* GMP-aligned pharmacy accountability procedures
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Be randomized to receive either vancomycin or placebo orally twice daily for 4 weeks.
Undergo clinical assessments including Mayo scoring, endoscopic evaluation, and laboratory testing at baseline, week 4, and follow-up.
After 4 weeks, have the option to receive open-label vancomycin for an additional 4 weeks.
Provide stool and blood samples for microbiome and biochemical analyses.
Be monitored for adverse events and treatment adherence throughout the trial.
TREATMENT
QUADRUPLE
Study Groups
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Placebo Comparator
4 weeks blinded placebo followed by optional 4 weeks open-label vancomycin.
Placebo (blinded)
Identical placebo capsule administered orally twice daily for 4 weeks.
Vancomycin (open-label extension)
Vancomycin 250 mg administered orally twice daily for 4 weeks (optional extension offered to both arms).
Vancomycin
4 weeks blinded oral vancomycin followed by optional additional 4 weeks open-label vancomycin.
Vancomycin (blinded)
Vancomycin 250 mg administered orally twice daily for 4 weeks.
Vancomycin (open-label extension)
Vancomycin 250 mg administered orally twice daily for 4 weeks (optional extension offered to both arms).
Interventions
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Placebo (blinded)
Identical placebo capsule administered orally twice daily for 4 weeks.
Vancomycin (blinded)
Vancomycin 250 mg administered orally twice daily for 4 weeks.
Vancomycin (open-label extension)
Vancomycin 250 mg administered orally twice daily for 4 weeks (optional extension offered to both arms).
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of UC and PSC.
* Moderate to severe UC disease activity (total Mayo score ≥5; endoscopic subscore ≥2).
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Weston Family Foundation
OTHER
McMaster University
OTHER
Responsible Party
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Principal Investigators
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Neeraj Narula, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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McMaster Children's Hospital - Digestive Diseases Clinic
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Ullman TA, Itzkowitz SH. Intestinal inflammation and cancer. Gastroenterology. 2011 May;140(6):1807-16. doi: 10.1053/j.gastro.2011.01.057.
Uzdzicki AW, Wawrzynowicz-Syczewska M. Characteristic features of ulcerative colitis with concomitant primary sclerosing cholangitis. Prz Gastroenterol. 2021;16(3):184-187. doi: 10.5114/pg.2021.108983. Epub 2021 Sep 17.
Arbabzada N, Dennett L, Meng G, Peerani F. The Effectiveness of Oral Vancomycin on Inflammatory Bowel Disease in Patients With Primary Sclerosing Cholangitis: A Systematic Review. Inflamm Bowel Dis. 2025 Jul 7;31(7):2027-2035. doi: 10.1093/ibd/izae257.
Shah A, Macdonald GA, Morrison M, Holtmann G. Targeting the Gut Microbiome as a Treatment for Primary Sclerosing Cholangitis: A Conceptional Framework. Am J Gastroenterol. 2020 Jun;115(6):814-822. doi: 10.14309/ajg.0000000000000604.
Al Sulais E, AlAmeel T, Alenzi M, Shehab M, AlMutairdi A, Al-Bawardy B. Colorectal Neoplasia in Inflammatory Bowel Disease. Cancers (Basel). 2025 Feb 16;17(4):665. doi: 10.3390/cancers17040665.
Castano-Milla C, Chaparro M, Gisbert JP. Systematic review with meta-analysis: the declining risk of colorectal cancer in ulcerative colitis. Aliment Pharmacol Ther. 2014 Apr;39(7):645-59. doi: 10.1111/apt.12651.
Lutgens MW, van Oijen MG, van der Heijden GJ, Vleggaar FP, Siersema PD, Oldenburg B. Declining risk of colorectal cancer in inflammatory bowel disease: an updated meta-analysis of population-based cohort studies. Inflamm Bowel Dis. 2013 Mar-Apr;19(4):789-99. doi: 10.1097/MIB.0b013e31828029c0.
Lundberg Bave A, Bergquist A, Bottai M, Warnqvist A, von Seth E, Nordenvall C. Increased risk of cancer in patients with primary sclerosing cholangitis. Hepatol Int. 2021 Oct;15(5):1174-1182. doi: 10.1007/s12072-021-10214-6. Epub 2021 Aug 6.
Risques RA, Lai LA, Himmetoglu C, Ebaee A, Li L, Feng Z, Bronner MP, Al-Lahham B, Kowdley KV, Lindor KD, Rabinovitch PS, Brentnall TA. Ulcerative colitis-associated colorectal cancer arises in a field of short telomeres, senescence, and inflammation. Cancer Res. 2011 Mar 1;71(5):1669-79. doi: 10.1158/0008-5472.CAN-10-1966.
Other Identifiers
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DRIVE_UP2025
Identifier Type: -
Identifier Source: org_study_id
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