Status:
COMPLETED
Efficacy of BIO-K+ CL1285® Prophylaxis in the Prevention of Traveler's Diarrhea in Adults
Lead Sponsor:
Bio-K Plus International Inc.
Collaborating Sponsors:
ethica Clinical Research Inc.
Conditions:
Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the efficacy of Bio-K+ CL1285 in reducing traveler's diarrhea.
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+...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
277 Patients enrolled
Trial Details
Trial ID
NCT00737412
Start Date
April 1 2008
End Date
January 1 2010
Last Update
January 21 2010
Active Locations (4)
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1
Clinique Santé Voyage des Prairies
Joliette, Quebec, Canada, J6E 1G2
2
Clinique Santé Voyage de Laval
Laval, Quebec, Canada, H7G2E6
3
Clinique Santé Voyage Saint-Luc
Montreal, Quebec, Canada, H2X 2H9
4
Sant Voyage Medisys
Montreal, Quebec, Canada, H3A 3C6