NCT04246151

Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients

Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients (Decency-RCT): A Randomized Controlled Pilot Trial

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this pilot study is to assess the feasibility of randomizing hospitalized patients that are colonized with C. difficile and started on systemic antibiotics to either a probiotic, oral vancomycin, or placebo in a parallel-group 1:1:1 design. The ultimate goal is to conduct an appropriately-powered RCT to determine the optimal method for reducing C difficile infection in colonized patients.

Detailed description

In this study, patients will be screened for C. difficile colonization

Conditions

• Clostridium Difficile Colonization
• Clostridium Difficile Diarrhea

Interventions

Type	Name	Description
DRUG	Vancomycin	Vancomycin capsules
DIETARY_SUPPLEMENT	Culturelle	Culturelle capsules
DRUG	Vancomycin Placebo	sugar pill manufactured to mimic the vancomycin 125 mg capsule
DRUG	Probiotic Placebo	sugar pill manufactured to mimic 10 billion unit probiotic capsules.

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-09-12
• Completion: 2024-09-12
• First posted: 2020-01-29
• Last updated: 2025-02-20

Locations

2 sites across 1 country: Canada