Travelers' Diarrhea Clinical Trial
Official title:
A Parallel, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Probiotic Formula in the Prevention of Traveler's Diarrhea
The present study is designed to evaluate the effect of a mixture of probiotics on the
prevention of traveler's diarrhea (TD) in subjects who travel to a country with a high risk
for developing TD. Subjects will be asked to take one capsule containing a mixture of
probiotics or a placebo capsule a day, within the week before departure, during the travel
and up to 3 days after return. They will note the following outcomes in a diary: occurence
of diarrhea, number and consistency of stools, duration of the diarrhea, presence of
diarrhea-related symptoms and need for rescue medication.
The present study will examine if the use of the probiotics capsule reduces the occurence of
traveler's diarrhea as compared to the placebo capsule.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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