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

NCT ID: NCT00328263

Last Updated: 2014-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 472 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-10-31

Brief 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.

Detailed 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.

Conditions

Diarrhea; Clostridium Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

Bio-K Cl1285 Bio-K Cl1285 contains 50 billion of live bacteria.

Group Type: EXPERIMENTAL

Lactobacillus acidophilus CL1285 and Lactobacillus casei

Intervention Type: DIETARY_SUPPLEMENT

One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.

2

placebo devoid of bacteria

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

placebo

One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

BioK CL1285

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JSS Medical Research Inc.

INDUSTRY

Sponsor Role: collaborator

Bio-K Plus International Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joe S Dylewski, MD

Role: PRINCIPAL_INVESTIGATOR

St-Mary Hospital Center

Locations

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

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

Countries

Canada

Other Identifiers

CL1285-AAD-M01

Identifier Type: -

Identifier Source: org_study_id