NCT00958308

Efficacy and Safety Study in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection

A Double-blind, Randomized, Placebo-controlled, Single-center Study of the Efficacy and Safety of BIO-K+ CL-1285® in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Bio-K Plus International Inc. · Industry
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Bio-K+ CL-1285 in the prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated Diarrhea (CDAD) in hospitalized patients exposed to nosocomial infection.

Conditions

• Antibiotic-Associated Diarrhea
• Clostridium Difficile-Associated Diarrhea

Interventions

Type	Name	Description
OTHER	BIO-K+ CL-1285®	A mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.
OTHER	Placebo	Placebo is devoid of microorganisms.

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-03-01
• Completion: 2009-04-01
• First posted: 2009-08-13
• Last updated: 2012-03-13
• Results posted: 2012-03-02