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| Name | Class |
|---|---|
| ethica Clinical Research Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | The probiotic Bio-K+ CL1285 RX® |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic: Bio-K+ CL1285 | Other | The probiotic Bio-K+ CL1285 RX®, a mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominique Tessier, MD | Sante Voyage Medisys | Principal Investigator |
| Benoit Brizard, MD | Clinique Santé Voyage de Laval | Principal Investigator |
| Benoit Cote, MD | Clinique Sante Voyage des Prairies | Principal Investigator |
| Jean Vincelette, MD | Sante Voyage Saint-Luc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Santé Voyage des Prairies | Joliette | Quebec | J6E 1G2 | Canada | ||
| Clinique Santé Voyage de Laval |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 14, 2016 | |
| Reset | Feb 11, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 14, 2016 | Feb 11, 2016 |
| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Placebo | Other | Matching capsules devoid of microorganisms |
|
| 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 |
| Laval |
| Quebec |
| H7G2E6 |
| Canada |
| Clinique Santé Voyage Saint-Luc | Montreal | Quebec | H2X 2H9 | Canada |
| Sant Voyage Medisys | Montreal | Quebec | H3A 3C6 | Canada |