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

This study has been completed.
Sponsor:
Collaborator:
JSS Medical Research Inc.
Information provided by (Responsible Party):
Bio-K Plus International Inc.
ClinicalTrials.gov Identifier:
NCT00328263
First received: May 17, 2006
Last updated: July 15, 2014
Last verified: July 2014
Results First Received: August 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Diarrhea
Clostridium Infections
Interventions: Dietary Supplement: Lactobacillus acidophilus CL1285 and Lactobacillus casei
Dietary Supplement: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
2151 patients were screened for eligibility. 437 patients were randomized for the study between March 2006 and October 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Inclusion & exclusion criterias were used to randomized patients. Patients were followed for an additionnal 21 days after treatment ended.

Reporting Groups
  Description
Bio-K+ CL1285 98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
Placebo 98g/day of placebo (devoid of microorganisms)

Participant Flow:   Overall Study
    Bio-K+ CL1285     Placebo  
STARTED     216     221  
COMPLETED     213 [1]   217 [2]
NOT COMPLETED     3     4  
[1] 3 deaths occured during the study. None of the deaths were causally related to the study product.
[2] 4 deaths occured during the study. None of the deaths were causally related to the study product.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Bio-K+ CL1285 98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
Placebo 98g/day of placebo (devoid of microorganisms)
Total Total of all reporting groups

Baseline Measures
    Bio-K+ CL1285     Placebo     Total  
Number of Participants  
[units: participants]
  216     221     437  
Age  
[units: years]
Mean ± Standard Deviation
  59.5  ± 18.1     58.1  ± 19.1     58.8  ± 18.6  
Gender  
[units: participants]
     
Female     99     114     213  
Male     117     107     224  
Region of Enrollment  
[units: participants]
     
Canada     216     221     437  



  Outcome Measures

1.  Primary:   The Incidence of Antibiotic-associated Diarrhea.   [ Time Frame: Up to 40 days ]

2.  Secondary:   Positive Results for Clostridium Difficile (C. Difficile) Toxin A or B in Antibiotic Associated Diarrhea Patients.   [ Time Frame: Up to 40 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  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   [ Time Frame: Up to 40 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Safety Profile of BIO-K+CL1285® Versus Placebo in Patients on Antibiotics   [ Time Frame: Up to 40 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Serge Carrière
Organization: Bio-K+ International Inc.
phone: 450-978-2465
e-mail: scarriere@biokplus.com


No publications provided


Responsible Party: Bio-K Plus International Inc.
ClinicalTrials.gov Identifier: NCT00328263     History of Changes
Other Study ID Numbers: CL1285-AAD-M01
Study First Received: May 17, 2006
Results First Received: August 28, 2012
Last Updated: July 15, 2014
Health Authority: Canada: Health Canada