Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328263
• Other study ID #: CL1285-AAD-M01
• Status: Completed
• Phase: Phase 3
• First received: May 17, 2006
• Last updated: July 15, 2014
• Start date: March 2006
• Est. completion date: October 2007

Study information

• Verified date: July 2014
• Source: Bio-K Plus International Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: October 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• presenting to the Emergency Room and considered for admission to hospital for a minimum of 12 hours and requiring antibiotic administration for the treatment of a suspected or proven bacterial infection OR a hospitalized patient developing a suspected or proven nosocomial infection OR an external patient that come to the hospital for repeated visits to receive his intravenous antibiotic therapy for the treatment of a suspected or proven bacterial infection. The external patients on oral antibiotics that come to the hospital for repeated visits to receive any other treatments requiring a hospital stay of more than one hour will also be included.

• Hospital employee on antibiotics can also be included in the study

• having received less than 24 hours of antibiotic therapy;

• requiring a minimum of 3 days and a maximum of 14 days antibiotic administration

Informed consent must be obtained in writing for all subjects at enrollment into the study

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

• active diarrhea;

• a history of daily consumption of fermented milk and/or yogurt;

• intolerance to lactose;

• pregnant/breastfeeding women;

• an active, non controlled intestinal disease such as Crohn's Disease or ulcerative colitis;

• ileostomy, jejunostomy or colostomy;

• immunosuppressed state;

• a previous documented C. difficile infection in the three months prior to study initiation;

• active radiotherapy or chemotherapy;

• recent (< 6 months) or planned bone marrow graft or organ transplant;

• antibiotic therapy in the fourteen days prior to study initiation;

• the planned administration of metronidazole (alone or in combination) or vancomycin monotherapy for the treatment of an infection;

• mental or other conditions, or language barriers rendering the subject unable to understand the nature, scope, and possible consequences of the study or complete the self-administered questionnaires;

• subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.

Post-enrollment exclusion criteria include fermented milk and/or yogurt consumption during the study period and two consecutive missed dose of study product.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Clostridium Infections
• Diarrhea

Intervention

Dietary Supplement:
• Lactobacillus acidophilus CL1285 and Lactobacillus casei
One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.
• placebo
One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.

Locations

Country	Name	City	State
Canada	Hotel Dieu de Chicoutimi	Chicoutimi	Quebec
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	St-Mary Hospital Center	Montreal	Quebec
Canada	Laval Hospital	Quebec
Canada	Hotel-Dieu de St-Jerome	St-Jerome	Quebec
Canada	North York General Hospital	Toronto	Ontario
Canada	Centre Hospitalier Régional de Trois-Rivières	Trois-Rivieres	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Bio-K Plus International Inc.	JSS Medical Research Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Incidence of Antibiotic-associated Diarrhea.	Presence of at least one diarrhea episode within 24 hours.	Up to 40 days	No
Secondary	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.	Up to 40 days	No
Secondary	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		Up to 40 days	No
Secondary	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	Up to 40 days	Yes