Diarrhea Clinical Trial
Official title:
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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