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

The prevalence of Clostridium difficile infection (CDI) has been on the rise in the United States, and in fact the Centers for Disease Control and Prevention (CDC) identified CDI as one of the highest threats in its recent report on antibiotic resistance in the United States. This designation as an "urgent threat" highlights the need for immediate and aggressive action to prevent this infection.

In fact, CDI has been reported as the most commonly reported pathogen causing healthcare-associated infections (HAIs). A point prevalence survey of 183 hospitals in 10 states found that C. difficile comprised 12.1% of HAIs, surpassing Staphylococcus aureus infections.

Although most cases of CDI can be treated successfully with relatively safe and effective oral antibiotics (i.e., metronidazole or vancomycin), primary prevention of CDI is critical because up to one in five treated patients endures a relapse or reinfection, which can be difficult to treat; infected patients serve as a reservoir for ongoing transmission within facilities; implementation of contact isolation precautions for patients who have CDI can have deleterious consequences for the patient; and, CDI can result in death or severe disease including those treated by colectomy. Because CDI is spread between patients, prevention of a single case should reduce the risk of exposure for other hospital patients.

One of the main studies in this indication, being a quality improvement study conducted at Pierre Le Gardeur Hospital (PLGH) in province of Québec, Canada. Starting in 2004, 10 years of surveillance data were reported from this hospital that administers Bio-K Plus to all antibiotic users. During the 10 years of observation, 44, 835 inpatients received Bio-K+, and the CDI rate at PLGH declined from 18.0 cases per 10,000 patient-days and remained at low mean levels of 2.3 cases per 10 000 patient-days.

Additionally, 10-year data collected by the Ministry of Health in Quebec comparing the CDI rate between Quebec hospitals showed that CDI rates at PLGH were consistently and continuously lower compared with those at similar hospitals.