Vancomycin vs Probiotics for Clostridium Difficile Infection

(Decency-RCT Trial)

Recruiting at1 trial location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Hamilton Health Sciences Corporation

Trial Summary

What is the purpose of this trial?

This trial is testing probiotics and an antibiotic called vancomycin in hospitalized patients who have C. difficile bacteria in their gut and are starting antibiotics. The goal is to find the best way to prevent these patients from getting a C. difficile infection. Probiotics have been studied and shown promising effects in preventing Clostridium difficile-associated diarrhea (CDAD).

Research Team

Eligibility Criteria

Adults over 18, colonized with C. difficile but not showing infection symptoms, who've started systemic antibiotics within the last 72 hours can join. They must have recent vital signs and blood tests recorded. Excluded are those allergic to study drugs or milk, pregnant/breastfeeding women, patients with certain heart diseases, hearing loss, severe kidney issues or on specific medications.

Inclusion Criteria

My recent health checks and kidney function tests are up to date.

I have started taking antibiotics for an infection.

I am 18 or older and carry C. difficile without showing symptoms.

Exclusion Criteria

I started taking antibiotics more than 3 days ago.

You have had an allergic reaction to one of the study drugs or have a sensitivity to milk.

I have a history of serious gut conditions like Crohn's disease or ulcerative colitis.

Treatment Details

Interventions

• Culturelle (Probiotic)
• Probiotic Placebo (Other)
• Vancomycin (Glycopeptide Antibiotic)
• Vancomycin Placebo (Other)

Trial Overview The trial is testing if taking Culturelle (a probiotic), oral Vancomycin (an antibiotic), or a placebo prevents C. difficile infection in hospitalized patients already carrying the bacteria but not infected. Participants will be randomly assigned to one of these three options in equal numbers.

Participant Groups

Group I: Vancomycin & probiotic placebo Experimental Treatment 2 Interventions

Vancomycin 125 mg orally every 12 hours plus probiotic placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days.

Group II: Probiotic & vancomycin placebo Experimental Treatment 2 Interventions

Culturelle probiotic 20 billion active units orally every 12 hours plus vancomycin placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days.

Group III: Probiotic placebo & vancomycin placebo Placebo Group 2 Interventions

Vancomycin placebo orally every 12 hours and Culturelle placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days.

Who Is Running the Clinical Trial?

Hamilton Health Sciences Corporation

Lead Sponsor

Trials

380

Recruited

345,000+

Dr. Craig A. VanHelder

Hamilton Health Sciences Corporation

Chief Medical Officer since 2023

MD

Tracey MacArthur

Hamilton Health Sciences Corporation

Chief Executive Officer

MSc in Quality Improvement & Patient Safety from the University of Toronto, Honours BA in Psychology from the University of Waterloo, Masters Certificate in Project Management from the Schulich School of Business at York University