- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00328263
Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Quebec, Canada, G1V 4G5
- Laval Hospital
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Ontario
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Hamilton, Ontario, Canada, L8L-2X2
- Hamilton General Hospital
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Kingston, Ontario, Canada, K7L 2V7
- Kingston General Hospital
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Toronto, Ontario, Canada, M2K 1E1
- North York General Hospital
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Quebec
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Chicoutimi, Quebec, Canada, G7H5H6
- Hotel Dieu de Chicoutimi
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Montreal, Quebec, Canada, H3T 1M5
- St-Mary Hospital Center
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St-Jerome, Quebec, Canada, J7Z 5T3
- Hotel-Dieu de St-Jerome
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Trois-Rivieres, Quebec, Canada, G8Z 3R9
- Centre Hospitalier Regional de Trois-Rivieres
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Bio-K Cl1285 Bio-K Cl1285 contains 50 billion of live bacteria.
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One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.
Other Names:
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Placebo Comparator: 2
placebo devoid of bacteria
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One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Incidence of Antibiotic-associated Diarrhea.
Time Frame: Up to 40 days
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Presence of at least one diarrhea episode within 24 hours.
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Up to 40 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive Results for Clostridium Difficile (C. Difficile) Toxin A or B in Antibiotic Associated Diarrhea Patients.
Time Frame: Up to 40 days
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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.
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Up to 40 days
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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
Time Frame: Up to 40 days
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Up to 40 days
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Safety Profile of BIO-K+CL1285® Versus Placebo in Patients on Antibiotics
Time Frame: Up to 40 days
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Safety was assessed by the incidence of treatment-emerged adverse events, which were reported according to MedDRA 10.1
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Up to 40 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joe S Dylewski, MD, St-Mary Hospital Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL1285-AAD-M01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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