Study of Bio-K+® in the Reduction of the Risk of Clostridium Difficile Infection and Antibiotic Associated Diarrhea

Phase 4

Terminated

• Conditions: Clostridium Difficile Infection; Antibiotic Associated Diarrhea
• Interventions: Dietary Supplement: Bio K+® 2 capsules orally (or via nasogastric tube); Dietary Supplement: Placebo

• Registration Number: NCT01972932
• Lead Sponsor: Bio-K Plus International Inc.

Brief Summary

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.

Detailed Description

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.

In conclusion, adding Bio-K Plus as a standard treatment led to a dramatic and sustained decrease in the incidence of C. difficile infections at this hospital.

Study Timeline

• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-10-31
• Study Start: 2013-11
• Primary Completion: 2014-11
• Study Completion: 2017-08
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-21
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bio K+®	Bio K+® 2 capsules orally (or via nasogastric tube)	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	Placebo	Placebo 2 capsules orally (or via nasogastric tube) once per day starting randomization until five days after the discontinuation of the antibiotic.

Primary Outcome Measures

Name	Time	Method
To evaluate the incidence of Clostridium Difficile infection	2 Years	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.

Secondary Outcome Measures

Name	Time	Method
To evaluate the incidence of antibiotic associated diarrhea	2 Years	* 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+®

Trial Locations

Locations (1)

Centre Hospitalier de l'Université de Montréal; 🇨🇦 Montreal, Quebec, Canada