This study is designed as a randomized double-blinded treatment trial among travelers' to geographical areas with moderate-severe rates of traveler's diarrhea. Travelers will be randomized to receive CBS 2004 or masked placebo to be taken daily while traveling. The test article or placebo will be taken starting 7 days prior to travel.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
CBS 2004 active treatment
Placebo treatment
Assess safety and tolerance by evaluating the adverse events reported with study drug and placebo during the period of prophylaxis and through the last clinic visit.
Time frame: 7 weeks
To assess the effectiveness of CBS 2004 by evaluating the development of traveler's diarrhea (TD) with CBS-2004 versus placebo based on time to first unformed stool associated with a TD episode
Time frame: 7 weeks
Assess the number of work days lost due to diarrhea
Time frame: 7 weeks
Assess percentages of subjects requiring treatment for diarrhea
Time frame: 7 weeks
Assess total number of diarrheal days
Time frame: 7 weeks
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