Recruiting
Phase 2

Vancomycin

Sponsor:

McMaster University

Code:

NCT07341282

Conditions

Ulcerative Colitis (UC)

Primary Sclerosing Cholangitis (PSC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Placebo (blinded)

Vancomycin (blinded)

Vancomycin (open-label extension)

Study Details

Brief 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)

Study ID

NCT07341282

Start date

Jun 17, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

14 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo Comparator

4 weeks blinded placebo followed by optional 4 weeks open-label vancomycin.

experimental: Vancomycin

4 weeks blinded oral vancomycin followed by optional additional 4 weeks open-label vancomycin.

Interventions

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).

Primary outcome measure

  • Recruitment rate [ Time Frame: 12 months ]
  • Retention rate [ Time Frame: 12 months ]
  • Treatment adherence [ Time Frame: 12 months ]
  • Protocol compliance with study procedures [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Neeraj Narula, MD

905-521-2100neeraj.narula@medportal.ca

Jaimin Patel

905-521-2100patej102@mcmaster.ca

Locations

McMaster Children's Hospital - Digestive Diseases Clinic

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

Neeraj Narula, MD

905-521-2100neeraj.narula@medportal.ca

Jaimin Patel

905-521-2100patej102@mcmaster.ca

Principal Investigator:

Neeraj Narula, MD

More Information

Sponsor

McMaster University

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

  • Ulcerative Colitis
  • Primary Sclerosing Cholangitis
  • Vancomycin
  • Randomized Control Trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by McMaster University on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.