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

Bio-K Plus

Status and phase

Completed

Phase 3

Conditions

Diarrhea

Treatments

Other: Placebo

Other: Probiotic: Bio-K+ CL1285

Study type

Interventional

Funder types

Industry

Identifiers

NCT00737412

CL1285-TD-M02

Details and patient eligibility

About

The purpose of this study is to determine the efficacy of Bio-K+ CL1285 in reducing traveler's diarrhea.

Full 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.

Enrollment

277 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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