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

ConditionsUlcerative Colitis (UC)Primary Sclerosing Cholangitis (PSC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMcMaster University

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo (blinded)

    Drug

    Identical placebo capsule administered orally twice daily for 4 weeks.

  • Vancomycin (blinded)

    Drug

    Vancomycin 250 mg administered orally twice daily for 4 weeks.

  • Vancomycin (open-label extension)

    Drug

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

Treatment groups

14 Participants
are divided into 2 treatment groups
Group A: Placebo ComparatorPlacebo comparator 2 interventions
Group B: VancomycinExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Recruitment rate

Proportion of eligible participants who provide consent and are enrolled in the study (number enrolled ÷ number eligible approached), with a target of 14 participants within 12 months.

Time frame
12 months
2

Retention rate

Proportion of enrolled participants who complete all protocol-specified study visits and assessments at 12 months (number completing all follow-up visits ÷ number enrolled).

Time frame
12 months
3

Treatment adherence

Proportion of prescribed oral vancomycin doses taken over the treatment period, assessed by pill counts and/or medication diary (number of doses taken ÷ number of doses prescribed).

Time frame
12 months
4

Protocol compliance with study procedures

Proportion of participants with all required visits, laboratory tests, and assessments completed per protocol (number fully compliant ÷ number enrolled); may also include rate of major protocol deviations.

Time frame
12 months

Secondary outcomes

1

Incidence of adverse events and serious adverse events

Proportion of participants with at least one treatment-emergent adverse event (AE) or serious adverse event (SAE)

Time frame
12 months
2

Severity and type of adverse events

Number of treatment-emergent AEs and SAEs by maximum severity grade (mild/moderate/severe) and type (MedDRA preferred term).

Time frame
12 months
3

Relationship of adverse events to oral vancomycin

Proportion of AEs/SAEs assessed by investigator as related to intervention (number related ÷ total events).

Time frame
12 months
4

Patient-reported tolerability of oral vancomycin

Mean score of side effect frequency and impact on 0-10 scale (0=no impact, 10=worst impact) via study questionnaire.

Time frame
12 months

Other outcomes

1

Exploratory Endpoints (Change in Mayo Score from baseline)

Change in partial Mayo Clinic Score (range 0-12 points, higher scores indicate greater ulcerative colitis disease activity) from baseline to 12 months.

Time frame
12 months
2

Exploratory Endpoints (Change in serum liver enzymes from baseline)

Change in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels (units: U/L) from baseline to 12 months.

Time frame
12 months
3

Exploratory Endpoints (Change in gut microbiome diversity from baseline)

Change in gut microbiome diversity (Shannon index, unitless) measured by 16S rRNA sequencing of fecal samples from baseline to 12 months.

Time frame
12 months
4

Exploratory Endpoints (Change in fecal bile acids from baseline)

Change in total fecal bile acid concentration (units: μmol/g) measured by mass spectrometry from baseline to 12 months.

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McMaster University

Lead sponsor

Weston Family Foundation

Collaborator

Source ClinicalTrials.gov
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