Status:
COMPLETED
Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients
Lead Sponsor:
Bio-K Plus International Inc.
Collaborating Sponsors:
JSS Medical Research Inc.
Conditions:
Diarrhea
Clostridium Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
472 Patients enrolled
Trial Details
Trial ID
NCT00328263
Start Date
March 1 2006
End Date
October 1 2007
Last Update
August 7 2014
Active Locations (8)
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1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L-2X2
2
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
3
North York General Hospital
Toronto, Ontario, Canada, M2K 1E1
4
Hotel Dieu de Chicoutimi
Chicoutimi, Quebec, Canada, G7H5H6