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Clinical Trial 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.


Clinical Trial Description

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


Study Design


Related Conditions & MeSH terms


NCT number NCT04246151
Study type Interventional
Source Hamilton Health Sciences Corporation
Contact Dominik Mertz, MD
Phone 905-525-9140
Email mertz@hhsc.ca
Status Recruiting
Phase Early Phase 1
Start date September 1, 2022
Completion date March 2024

See also
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Terminated NCT00772954 - Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity Phase 1
Recruiting NCT04305769 - Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT) Phase 2
Completed NCT00034294 - A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea Phase 2
Terminated NCT03793686 - A Study of Safety of PBCLN-003 Following Antibiotic Therapy in Subjects With C.Difficile-associated Diarrhea Phase 1
Recruiting NCT02200328 - Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients Phase 4
Recruiting NCT03141775 - Incidence and Economic Burden of Clostridium Difficile Infections (CDI) in the German Health Care System (IBIS) N/A