Efficacy of BIO-K+ CL1285® Prophylaxis in the Prevention of Traveler's Diarrhea in Adults
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.
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.
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