Ulcerative Colitis study: Vancomycin
Official title Investigation of Vancomycin Efficacy in Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis
ClinicalTrials.gov ID: NCT07341282
What this study is testing
What is Vancomycin (blinded)?
An investigational oral antibiotic being studied for treating active ulcerative colitis in adults with primary sclerosing cholangitis.
Also referred to as Vancomycin.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if vancomycin can reduce ulcerative colitis symptoms and if it is safe for people who also have a liver condition called primary sclerosing cholangitis.
- Who it's for
- Adults who have both ulcerative colitis and primary sclerosing cholangitis.
- What's involved
- Participants will take either vancomycin capsules (250 mg twice a day) or a matching placebo for 4 weeks, with clinic visits at the start, week 4, and a follow‑up. They may also choose to continue vancomycin for another 4 weeks after the blinded phase. Blood, stool, and endoscopy tests will be done to check safety and disease activity.
- Time commitment
- The study lasts about 8 weeks, with visits at baseline, week 4, and a follow‑up. Participants must take the medication as directed and attend all scheduled visits.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Hamilton, Ontario, Canada
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hamilton, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.