Efficacy of BIO-K+ CL1285® Prophylaxis in the Prevention of Traveler's Diarrhea in Adults (NCT00737412) | Clinical Trial Compass
CompletedPhase 3
Efficacy of BIO-K+ CL1285® Prophylaxis in the Prevention of Traveler's Diarrhea in Adults
Canada277 participantsStarted 2008-04
Plain-language summary
The purpose of this study is to determine the efficacy of Bio-K+ CL1285 in reducing traveler's diarrhea.
Who can participate
Age range18 Years
SexALL
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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 un…
What they're measuring
1
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.