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

NCT04246151 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2025-02-20

No results posted yet for this study

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.

Conditions

  • Clostridium Difficile Colonization
  • Clostridium Difficile Diarrhea

Interventions

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.

Sponsors & Collaborators

  • Hamilton Health Sciences Corporation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-09-12
Completion
2024-09-12

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04246151 on ClinicalTrials.gov