Testing Vancomycin (blinded) with Vancomycin (open-label extension) against a placebo for ulcerative colitis (UC)
Official title: Investigation of Vancomycin Efficacy in Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis
- Phase 2
- 2 groups
- One site, in Hamilton
- Recruiting
Interventions
- Medication
Placebo (blinded)
Identical placebo capsule administered orally twice daily for 4 weeks.
- Medication
Vancomycin (blinded)
Vancomycin 250 mg administered orally twice daily for 4 weeks.
- Medication
Vancomycin (open-label extension)
Vancomycin 250 mg administered orally twice daily for 4 weeks (optional extension offered to both arms).
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
McMaster Children's Hospital - Digestive Diseases Clinic
Hamilton, Ontario
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Prior allergy or intolerance to Vancomycin
- +Adults aged ≥18 years.
- +Confirmed diagnosis of UC and PSC.
- +Moderate to severe UC disease activity (total Mayo score ≥5; endoscopic subscore ≥2).
- +Informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → provided. Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +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.
- +History of hearing loss or current hearing problems
- +Pregnancy or lactation.
Exclusion
- −Prior allergy or intolerance to Vancomycin
- −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.
- −History of hearing loss or current hearing problems
- −Pregnancy or lactation.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives one or more of: Placebo (blinded) and Vancomycin (open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more → extension).
Registry label: A: Placebo Comparator
Group B receives one or more of: Vancomycin (blinded) and Vancomycin (open-label extension).
Registry label: B: Vancomycin
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 14 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: 12 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Recruitment rate — measured over 12 months.
Retention rate — measured over 12 months.
Treatment adherence — measured over 12 months.
ProtocolProtocolThe detailed plan a study must follow.Read more → compliance with study procedures — measured over 12 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07341282 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Placebo (blinded)Drug
Identical placebo capsule administered orally twice daily for 4 weeks.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Vancomycin (blinded)Drug
Vancomycin 250 mg administered orally twice daily for 4 weeks.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Vancomycin (open-label extension)Drug
Vancomycin 250 mg administered orally twice daily for 4 weeks (optional extension offered to both arms).
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 12 months.
The study as a whole is currently expected to finish around 2027-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 14 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Hamilton, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.