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

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.

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