Study of Bio-K+® in the Reduction of the Risk of Clostridium Difficile Infection and Antibiotic Associated Diarrhea
Antibiotic-associated diarrhea (AAD) and particularly Clostridium difficile-Infection (CDI) are the most common causes of healthcare associated infectious diarrhea. In light of the results obtained in a limited number of randomized clinical trials in subjects with AAD and CDI in comparison with the widespread occurrence of these diseases, it is felt that the addition of a well-controlled clinical trial in a western environment would add value to support the use of a specific probiotic to counteract these diseases.
Clostridium Difficile Infection
Antibiotic Associated Diarrhea
Dietary Supplement: Bio-K®
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Protocol CHUM 2014-5056: A Randomized, Double Blinded Placebo Controlled Study to Evaluate the Efficacy of Bio-K+® in the Reduction of the Risk of Clostridium Difficile Infection and Antibiotic Associated Diarrhea in Hospitalized Patients|
- To evaluate the incidence of Clostridium Difficile infection [ Time Frame: 2 Years ] [ Designated as safety issue: No ]The primary objective of this study is evaluate the incidence risk ratio of CDI in hospitalized subjects treated with systemic antibiotics, taking oral administration of Bio-K+® in comparison with a placebo. Risk will be calculated for the period of antibiotic treatment plus 65 days.
- To evaluate the incidence of antibiotic associated diarrhea [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- To evaluate the incidence of AAD
- To evaluate the incidence of RCDI
- To determine the time to occurrence of the first symptoms (first liquid stool) of AAD or CDI -
- To evaluate the impact on the duration of hospitalization
- To evaluate the number of emergency room visits and re-hospitalizations for AAD or CDI
- To determine the mean costs for the initial hospitalization
- To evaluate the safety profile of Bio-K+®
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: 2 capsules orally (or via nasogastric tube)
Placebo 2 capsules orally (or via nasogastric tube) once per day starting randomization until five days after the discontinuation of the antibiotic.
Experimental: Bio K+® 2 capsules orally (or via nasogastric tube)
Subjects who meet all inclusion/exclusion criteria will be randomized to one of the following study arms: Bio K+® 2 capsules orally (or via nasogastric tube) once per day starting at randomization until five days after the discontinuation of the antibiotic. Placebo 2 capsules orally (or via nasogastric tube) once per day starting randomization until five days after the discontinuation of the antibiotic.
Assignment to the study arms will be based on a computer-generated randomization schedule prepared by a statistician before the start of the study. Subjects will be randomized in blocks of six (3 in each group), stratified by service (internal medicine, pneumology, cardiac surgery and vascular surgery). Blocks will be independent for each Hospital to ensure optimal randomization.
Dietary Supplement: Bio-K®
2 ARMS STUDY
Other Name: Bio-K®
|Centre Hospitalier de l'Université de Montréal||Recruiting|
|Montreal, Quebec, Canada|
|Contact: Mikhael Laskine, MD 514 890 8000 ext 1462 email@example.com|
|Principal Investigator: Madeleine Durand, MD|
|Principal Investigator:||Mikhael Laskine, MD||Centre Hospitalier de l'Université de Montréal|
|Study Director:||Serge Carriere, MD||Bio-K+International Inc.|