MedTrace Logo

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

NCT07341282 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-01-14

No results posted yet for this 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.

Conditions

  • Ulcerative Colitis (UC)
  • Primary Sclerosing Cholangitis (PSC)

Interventions

DRUG

Placebo (blinded)

Identical placebo capsule administered orally twice daily for 4 weeks.

DRUG

Vancomycin (blinded)

Vancomycin 250 mg administered orally twice daily for 4 weeks.

DRUG

Vancomycin (open-label extension)

Vancomycin 250 mg administered orally twice daily for 4 weeks (optional extension offered to both arms).

Sponsors & Collaborators

Principal Investigators

  • Neeraj Narula, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-12-31
Completion
2027-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07341282 on ClinicalTrials.gov