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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
472
One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.
One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.
Hamilton General Hospital
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
North York General Hospital
Toronto, Ontario, Canada
Hotel Dieu de Chicoutimi
Chicoutimi, Quebec, Canada
The Incidence of Antibiotic-associated Diarrhea.
Presence of at least one diarrhea episode within 24 hours.
Time frame: Up to 40 days
Positive Results for Clostridium Difficile (C. Difficile) Toxin A or B in Antibiotic Associated Diarrhea Patients.
Testing for CDAD was performed at the discretion of the treating physician and according to the protocol in place at the study centers. CDAD was defined as an episode of diarrhea and positive results for C. difficile Toxin A or B.
Time frame: Up to 40 days
Health Outcome Evaluation Will Look at the Direct Medical Costs and Clinical Outcomes of Alternative Strategies in the Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients
Time frame: Up to 40 days
Safety Profile of BIO-K+CL1285® Versus Placebo in Patients on Antibiotics
Safety was assessed by the incidence of treatment-emerged adverse events, which were reported according to MedDRA 10.1
Time frame: Up to 40 days
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St-Mary Hospital Center
Montreal, Quebec, Canada
Laval Hospital
Québec, Quebec, Canada
Hotel-Dieu de St-Jerome
Saint-Jérôme, Quebec, Canada
Centre Hospitalier Régional de Trois-Rivières
Trois-Rivières, Quebec, Canada