Efficacy of BIO-K+ CL1285® Prophylaxis in the Prevention of Traveler's Diarrhea in Adults
Phase 3
Completed
- Conditions
- Diarrhea
- Interventions
- Other: Placebo
- Registration Number
- NCT00737412
- Lead Sponsor
- Bio-K Plus International Inc.
- 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+ CL-1285 OR placebo prophylaxis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 277
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo Placebo
- Primary Outcome Measures
Name Time Method 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. March 2008 to April 2009
- Secondary Outcome Measures
Name Time Method To compare the severity of diarrhea in travelers during their stay abroad and upon their return to Canada, following either BIO-K+CL1285 RX® or placebo prophylaxis. March 2008 to April 2009 To compare the safety profile of BIO-K+CL1285 RX® to that of placebo March 2008 to April 2009 To compare the physician and traveler satisfaction following daily prophylaxis with either BIO-K+CL1285 RX® or placebo March 08 to April 09 To evaluate and compare the health economic impact of daily prophylaxis with BIO-K+CL1285 RX®. March 08 to April 09
Trial Locations
- Locations (4)
Clinique Santé Voyage des Prairies
🇨🇦Joliette, Quebec, Canada
Clinique Santé Voyage de Laval
🇨🇦Laval, Quebec, Canada
Sant Voyage Medisys
🇨🇦Montreal, Quebec, Canada
Clinique Santé Voyage Saint-Luc
🇨🇦Montreal, Quebec, Canada