Vancomycin for Ulcerative Colitis

(DRIVE-UP Trial)

Overseen By Jaimin Patel

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: McMaster University

Must not be taking: Antibiotics, Probiotics

Disqualifiers: Crohn's, Fulminant colitis, Decompensated liver, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the antibiotic vancomycin can safely and effectively reduce symptoms in people with active ulcerative colitis (UC) who also have primary sclerosing cholangitis (PSC), a liver disease. Participants will take either vancomycin or a placebo (a pill with no active medicine) for four weeks to determine if vancomycin improves UC symptoms. Eligible participants should have moderate to severe UC and PSC, confirmed by a doctor. The trial will also assess vancomycin's safety for these patients. This study represents a small step toward understanding if vancomycin could benefit more people with these conditions in the future. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that oral vancomycin is safe for treating ulcerative colitis in adults with primary sclerosing cholangitis?

Research has shown that oral vancomycin is safe and effective for some individuals with inflammatory bowel disease (IBD) who also have primary sclerosing cholangitis (PSC). In certain studies, patients with ulcerative colitis (UC) who took vancomycin experienced improvement quickly, often within 4 to 6 weeks. Nearly half of the treated patients reported feeling better. So far, vancomycin appears well-tolerated, with no major safety concerns reported. This suggests that vancomycin could be a promising option, but further research is needed to confirm its safety and effectiveness for everyone. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Vancomycin is unique for treating ulcerative colitis because it targets harmful bacteria in the gut, potentially helping to reduce inflammation more directly than traditional therapies. Most standard treatments, like aminosalicylates and corticosteroids, focus on suppressing the immune system to manage inflammation, which can lead to various side effects. Researchers are excited about vancomycin because it offers a new approach by altering the gut's bacterial environment, potentially providing relief with fewer systemic effects. This could represent a significant shift in managing ulcerative colitis, offering a more targeted and potentially safer option for patients.

What evidence suggests that vancomycin might be an effective treatment for ulcerative colitis?

Research shows that oral vancomycin can help treat ulcerative colitis (UC), especially in individuals with primary sclerosing cholangitis (PSC). In this trial, some participants will receive vancomycin, while others will receive a placebo. Studies have found that vancomycin can significantly improve symptoms, with some patients feeling better in just 4-6 weeks. Additionally, vancomycin appears safe for these patients. Overall, evidence suggests that vancomycin can reduce UC symptoms and improve health outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Neeraj Narula, MD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for adults with both ulcerative colitis and primary sclerosing cholangitis. Participants must be able to take oral medication, attend several clinic visits, and comply with study procedures. Details on specific inclusions or exclusions are not provided.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with ulcerative colitis and primary sclerosing cholangitis.

Informed consent provided

Exclusion Criteria

My kidney function is severely impaired.

I have an infection that hasn't been treated yet.

Pregnancy or lactation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive oral vancomycin or placebo for 4 weeks

4 weeks

3 visits (in-person) at baseline, week 2, and week 4

Open-label extension

Participants have the option to receive open-label vancomycin for an additional 4 weeks

4 weeks

1 visit (in-person) at week 8

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) at week 8

What Are the Treatments Tested in This Trial?

Interventions

• Vancomycin

Trial Overview

The trial tests if vancomycin (250 mg twice daily) can improve ulcerative colitis symptoms over a period of 4 weeks compared to a placebo. After the initial phase, there's an option for another 4 weeks where everyone gets vancomycin.

How Is the Trial Designed?

Group I: Vancomycin Experimental Treatment 2 Interventions

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

Group II: Placebo Comparator Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Weston Family Foundation

Collaborator

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12235138/

The Effectiveness of Oral Vancomycin on Inflammatory ...

Oral vancomycin appears safe and effective to treat IBD in a subset of PSC patients. Future studies would benefit from prospective data ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07341282

Investigation of Vancomycin Efficacy in Patients With ...

This clinical trial tests if oral vancomycin can safely treat active ulcerative colitis (UC) in adults who also have primary sclerosing ...

3.

journals.lww.com

journals.lww.com/ajg/fulltext/2018/02001/therapeutic_effect_of_vancomycin_in_uc_patients.20.aspx

Therapeutic Effect of Vancomycin in UC Patients ...

Vancomycin was effective and safe at inducing clinical, biochemical and endoscopic remission. Clinical remission with vancomycin occurred rapidly within 4-6 ...

4.

eposters.ddw.org

eposters.ddw.org/ddw/2025/ddw-2025/4154938/prajith.raj.ramesh.oral.vancomycin.is.effective.therapy.in.patients.with.html?f=menu%3D6%2Abrowseby%3D8%2Asortby%3D2%2Ace_id%3D2855%2Aot_id%3D31400%2Amarker%3D5698

ORAL VANCOMYCIN IS EFFECTIVE THERAPY IN ...

Results: Ninety patients were identified (25.6% female); 80% had ulcerative colitis. Median age at IBD and PSC diagnoses was 16.4 and 17.4 years ...

5.

academic.oup.com

academic.oup.com/ecco-jcc/article/19/Supplement_1/i1902/7971937

P1031 Effectiveness and safety of oral vancomycin in the ...

Oral vancomycin is associated with improved inflammatory bowel disease clinical outcomes ... ulcerative colitis; fecal occult blood test ...

6.

healio.com

healio.com/news/gastroenterology/20250214/oral-vancomycin-may-offer-viable-option-for-ibdrelated-primary-sclerosing-cholangitis

Oral vancomycin may offer 'viable option' for IBD-related ...

Oral vancomycin therapy resulted in clinical response in nearly half of patients with inflammatory bowel disease associated with primary sclerosing cholangitis.