NCT00328263

Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients

A Double-blind, Randomized, Placebo Controlled, Multicenter Study of the Efficacy and Safety of BIO-K*+ CL-1285* in the Prevention of Antibiotic-associated Diarrhea in Adult Patients Exposed to Nosocomial Infection.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 472 (actual)
• Sponsor: Bio-K Plus International Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Bio-K + CL1285 versus placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients.

Detailed description

Antibiotic-associated diarrhea (AAD) is one of the most frequent adverse events following antibiotherapy and is the leading cause of diarrhea in hospitalized patients. Ten to 25% of AAD are caused by the bacteria Clostridium difficile. A recent unicenter study conducted at Maisonneuve-Rosemont hospital demonstrated the preventive role of Bio-K + CL1285 in antibiotic-associated diarrhea and Clostridium difficile-associated diarrhea. Its preventive role is thought to be mainly through restoration of the gastrointestinal flora affected in part by the antibiotherapy. A wide body of literature reveals clinical use of probiotics, but few well controlled prospective studies conducted on large numbers of subjects have been performed. In light of the positive preliminary results obtained in a limited number of patients with AAD and of the paucity of well controlled clinical trials, we now wish to undertake a randomized, double blind, multicentre study to evaluate the efficacy and safety of Bio-K + CL1285 prophylaxis vs. placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients. As secondary objectives, we also intend to evaluate the incidence of Clostridium difficile-associated diarrhea and to demonstrate that BIO-K + CL1285 agent will not only improve the clinical outcomes but also reduce health care expenditures.

Conditions

• Diarrhea
• Clostridium Infections

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus acidophilus CL1285 and Lactobacillus casei	One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.
DIETARY_SUPPLEMENT	placebo	One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-03-01
• Completion: 2007-10-01
• First posted: 2006-05-19
• Last updated: 2014-08-07
• Results posted: 2014-08-07

Locations

8 sites across 1 country: Canada