Diarrhea
Conditions
Keywords
Bio-K+CL1285, Probiotics, Traveler's Diarrhea, Lactobacillus Acidophilus, Lactobacillus Casei
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.
Interventions
OTHERProbiotic: Bio-K+ CL1285
The probiotic Bio-K+ CL1285 RX®, a mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.
OTHERPlacebo
Matching capsules devoid of microorganisms
Sponsors
ethica Clinical Research Inc.
Bio-K Plus International Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada
Outcome results
None listed