- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00737412
Efficacy of BIO-K+ CL1285® Prophylaxis in the Prevention of Traveler's Diarrhea in Adults
January 19, 2010 updated by: Bio-K Plus International Inc.
A Double-blind, Randomized, Placebo Controlled, Multicenter Study of the Efficacy of BIO-K+ CL1285® Prophylaxis in the Prevention of Traveler's Diarrhea in Adults.
The purpose of this study is to determine the efficacy of Bio-K+ CL1285 in reducing traveler's diarrhea.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Determine efficacy of Bio-K+ CL1285 in reducing Traveler's Diarrhea by comparing the incidence of diarrhea in travelers during their stay abroad and upon their return to Canada following either Bio-K+ CL-1285 OR placebo prophylaxis.
Study Type
Interventional
Enrollment (Actual)
277
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Joliette, Quebec, Canada, J6E 1G2
- Clinique Santé Voyage des Prairies
-
Laval, Quebec, Canada, H7G2E6
- Clinique Santé Voyage de Laval
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Montreal, Quebec, Canada, H2X 2H9
- Clinique Santé Voyage Saint-Luc
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Montreal, Quebec, Canada, H3A 3C6
- Sant Voyage Medisys
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female subjects over 18 years of age traveling to Mexico, Central America, South America and Caribbean Islands as direct destinations or on cruises to the same destinations.
- The trips last a minimum of 7 days and a maximum of 21 days.
- Women of child bearing capacity who are not pregnant at the moment of screening (pregnancy test done on-site) and agree to use an acceptable form of birth control for the duration of the study (e.g. Condom, oral contraceptives, etc.) are allowed to participate.
Exclusion Criteria:
- active diarrhea;
- pregnancy; breastfeeding
- 3 diarrheic episodes within 24 hours in the 15 days preceding the date of the departure;
- antibiotic treatment during the last 15 days or ongoing treatment at the time of departure;
- consumption of fermented milk, yogourt or probiotics probiotics in the 15 days preceding the date of the departure;
- immunosuppressed state or any health condition being susceptible to decompensate during the study (including malignant hemo-pathologies, AIDS, bone marrow transplant or organ transplant).
- active radiotherapy or chemotherapy as cancer treatment
- the administration of an ETEC/cholera vaccine or any other diarrhea vaccine in the three months prior to study initiation
- an active, non-controlled intestinal disease;
- ileostomy, jejunostomy or colostomy
- concomitant participation in another clinical trial
- 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, and unlikelihood of completing the study,
- allergies to any ingredients in the study product (active product or placebo)
- current use of illicit drug and alcohol abuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
|
Matching capsules devoid of microorganisms
|
Active Comparator: 1
The probiotic Bio-K+ CL1285 RX®
|
The probiotic Bio-K+ CL1285 RX®, a mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the efficacy of Bio-K+ CL1285 RX® in reducing traveler's diarrhea by comparing the incidence of diarrhea in travelers during their stay abroad and upon their return to Canada, following either BIO-K+CL1285 RX® or placebo prophylaxis.
Time Frame: March 2008 to April 2009
|
March 2008 to April 2009
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare the severity of diarrhea in travelers during their stay abroad and upon their return to Canada, following either BIO-K+CL1285 RX® or placebo prophylaxis.
Time Frame: March 2008 to April 2009
|
March 2008 to April 2009
|
To compare the safety profile of BIO-K+CL1285 RX® to that of placebo
Time Frame: March 2008 to April 2009
|
March 2008 to April 2009
|
To compare the physician and traveler satisfaction following daily prophylaxis with either BIO-K+CL1285 RX® or placebo
Time Frame: March 08 to April 09
|
March 08 to April 09
|
To evaluate and compare the health economic impact of daily prophylaxis with BIO-K+CL1285 RX®.
Time Frame: March 08 to April 09
|
March 08 to April 09
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dominique Tessier, MD, Sante Voyage Medisys
- Principal Investigator: Benoit Brizard, MD, Clinique Santé Voyage de Laval
- Principal Investigator: Benoit Cote, MD, Clinique Santé Voyage des Prairies
- Principal Investigator: Jean Vincelette, MD, Sante Voyage Saint-Luc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
August 15, 2008
First Submitted That Met QC Criteria
August 18, 2008
First Posted (Estimate)
August 19, 2008
Study Record Updates
Last Update Posted (Estimate)
January 21, 2010
Last Update Submitted That Met QC Criteria
January 19, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL1285-TD-M02
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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