Ulcerative Colitis (UC)Phase 2DRIVE-UPNCT07341282
Investigation of Vancomycin Efficacy in Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis
A Phase 2 study testing Vancomycin (blinded) and Vancomycin (open-label extension) in people with Ulcerative Colitis (UC) and Primary Sclerosing Cholangitis (PSC), run by McMaster University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (UC), Primary Sclerosing Cholangitis (PSC)
- What is being tested?
- Vancomycin (blinded) and Vancomycin (open-label extension)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jun 2026to Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McMaster Children's Hospital - Digestive Diseases Clinic
Hamilton, Ontario, L8N 3Z5
Neeraj Narula, MD, 905-521-2100 ext. 73884, neeraj.narula@medportal.ca
Jaimin Patel, 905-521-2100 ext. 73884, patej102@mcmaster.ca
About this study
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?
Read more
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.
Read the detailed description
This is an investigator-initiated feasibility study designed to rigorously characterize clinical response signals, safety parameters, and feasibility metrics in adults with co-existing PSC and UC, a population where microbiome-targeted immune modulation is hypothesized to influence disease activity.
Randomization \& Allocation Governance
- Randomization will be implemented using validated computer-generated randomization software, with the allocation sequence generated by a study statistician not involved in clinical assessments.
- Allocation concealment will be maintained through centralized pharmacy control. An independent pharmacist will assign treatment codes and release sequentially numbered study medication containers.
- Blinding integrity will be preserved through visual and packaging equivalence, sequential drug accountability logs, and restricted access to treatment codes until database lock.
- Emergency unblinding is permitted only when required for clinical management, and all unblinding events will be documented, timestamped, and reviewed by the DSMC.
Clinical Visit \& Assessment Schedule
Participants will complete a structured study visit pathway:
- Screening (≤14 days before baseline): medical history review, infection risk screening, liver disease stability assessment, and confirmation of clinical trial eligibility documentation.
- Baseline (Week 0): clinical evaluation, safety labs, medication reconciliation, and flexible sigmoidoscopy performed by credentialed endoscopists using a standardized endoscopic scoring handbook.
- Week 2 \& 4: in-clinic evaluation, adverse event review, safety labs, and compliance verification via pill count and participant diary reconciliation.
- Week 8 (extension follow-up): final safety labs, medication reconciliation, delayed adverse event capture, and optional qualitative feasibility interview.
Adherence \& Safety Surveillance
- Participants will complete weekly digital symptom and adherence diaries capturing stool frequency, rectal bleeding trends, abdominal pain patterns, and missed doses.
- Safety labs include CBC, creatinine, liver panel, CRP, albumin, electrolytes, and will be evaluated at baseline, week 2, 4, and 8.
- A hepatologist co-investigator will review liver safety signals in real-time, given PSC-specific vulnerability to hepatic decompensation.
- Audiology risk is screened at entry, and any symptoms concerning for ototoxicity will prompt same-week clinical review.
Data Capture \& Monitoring Integrity
- All data will be captured in a secure Excel file
- Endoscopic images will be stored in a secured institutional imaging server.
- A pre-registered statistical analysis plan will be finalized before unblinding, with analysis scripts locked prior to treatment code release.
Safety Governance Structure
The DSMC will provide independent oversight and safety adjudication:
- Quarterly DSMC meetings will evaluate cumulative safety logs, recruitment feasibility, protocol deviations, and unblinding reports.
- A real-time SAE notification system ensures DSMC alert within 24 hours of serious adverse event reporting.
- Pre-defined individual, arm-level, and whole-trial safety review thresholds are codified in the DSMC governance charter to support early pause or protocol modification when required.
Regulatory \& Ethical Compliance
The trial will follow all institutional and international regulatory standards:
- ICH-GCP
- Institutional Research Ethics Board approval
- DSMC governance charter
- GMP-aligned pharmacy accountability procedures
- Being tested
- Placebo (blinded), Vancomycin (blinded), Vancomycin (open-label extension)
- Keywords
- Ulcerative Colitis, Primary Sclerosing Cholangitis, Vancomycin, Randomized Control Trial
- Medical subject headings
- Colitis, Ulcerative, Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator | Placebo comparator | 4 weeks blinded placebo followed by optional 4 weeks open-label vancomycin. Receives: Drug: Placebo (blinded); Drug: Vancomycin (open-label extension) |
| Vancomycin | Experimental | 4 weeks blinded oral vancomycin followed by optional additional 4 weeks open-label vancomycin. Receives: Drug: Vancomycin (blinded); Drug: Vancomycin (open-label extension) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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).
Measured: 12 months
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).
Measured: 12 months
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.
Measured: 12 months
Secondary outcomes (4)
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)
Measured: 12 months
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).
Measured: 12 months
Relationship of adverse events to oral vancomycin
Proportion of AEs/SAEs assessed by investigator as related to intervention (number related ÷ total events).
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start17 Jun 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will: Be randomized to receive either vancomycin or placebo orally twice daily for 4 weeks. Undergo clinical assessments including Mayo scoring, endoscopic evaluation, and laboratory testing at baseline, week 4, and follow-up. After 4 weeks, have the option to receive open-label vancomycin for an additional 4 weeks. Provide stool and blood samples for microbiome and biochemical analyses. Be monitored for adverse events and treatment adherence throughout the trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Weston Family Foundation
- Responsible party
- Sponsor
- Investigators
- Neeraj Narula, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341282
- Sponsor's protocol ID
- DRIVE_UP2025
- Acronym
- DRIVE-UP
- Status last verified
- Oct 2026
- First submitted
- 2 Dec 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing policies would follow institutional and regulatory standards on data confidentiality and sharing. De-identified data shared upon request to qualified researchers with appropriate data use agreements, respecting participant confidentiality and ethical approvals. Patient demographics, primary data and data analysis can be shared.
Publications
Arbabzada N, Dennett L, Meng G, Peerani F. The Effectiveness of Oral Vancomycin on Inflammatory Bowel Disease in Patients With Primary Sclerosing Cholangitis: A Systematic Review. Inflamm Bowel Dis. 2025 Jul 7;31(7):2027-2035. doi: 10.1093/ibd/izae257.
PubMed 39495039Shah A, Macdonald GA, Morrison M, Holtmann G. Targeting the Gut Microbiome as a Treatment for Primary Sclerosing Cholangitis: A Conceptional Framework. Am J Gastroenterol. 2020 Jun;115(6):814-822. doi: 10.14309/ajg.0000000000000604.
PubMed 32250997Al Sulais E, AlAmeel T, Alenzi M, Shehab M, AlMutairdi A, Al-Bawardy B. Colorectal Neoplasia in Inflammatory Bowel Disease. Cancers (Basel). 2025 Feb 16;17(4):665. doi: 10.3390/cancers17040665.
PubMed 40002259Castano-Milla C, Chaparro M, Gisbert JP. Systematic review with meta-analysis: the declining risk of colorectal cancer in ulcerative colitis. Aliment Pharmacol Ther. 2014 Apr;39(7):645-59. doi: 10.1111/apt.12651.
PubMed 24612141Lutgens MW, van Oijen MG, van der Heijden GJ, Vleggaar FP, Siersema PD, Oldenburg B. Declining risk of colorectal cancer in inflammatory bowel disease: an updated meta-analysis of population-based cohort studies. Inflamm Bowel Dis. 2013 Mar-Apr;19(4):789-99. doi: 10.1097/MIB.0b013e31828029c0.
PubMed 23448792Lundberg Bave A, Bergquist A, Bottai M, Warnqvist A, von Seth E, Nordenvall C. Increased risk of cancer in patients with primary sclerosing cholangitis. Hepatol Int. 2021 Oct;15(5):1174-1182. doi: 10.1007/s12072-021-10214-6. Epub 2021 Aug 6.
PubMed 34357546Risques RA, Lai LA, Himmetoglu C, Ebaee A, Li L, Feng Z, Bronner MP, Al-Lahham B, Kowdley KV, Lindor KD, Rabinovitch PS, Brentnall TA. Ulcerative colitis-associated colorectal cancer arises in a field of short telomeres, senescence, and inflammation. Cancer Res. 2011 Mar 1;71(5):1669-79. doi: 10.1158/0008-5472.CAN-10-1966.
PubMed 21363920Ullman TA, Itzkowitz SH. Intestinal inflammation and cancer. Gastroenterology. 2011 May;140(6):1807-16. doi: 10.1053/j.gastro.2011.01.057.
PubMed 21530747Uzdzicki AW, Wawrzynowicz-Syczewska M. Characteristic features of ulcerative colitis with concomitant primary sclerosing cholangitis. Prz Gastroenterol. 2021;16(3):184-187. doi: 10.5114/pg.2021.108983. Epub 2021 Sep 17.
PubMed 34584578