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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
420
1 Capsule to be taken once a day during the entire study period
1 Capsule to be taken once a day during the entire study period
University of Milan
Milan, Italy
Occurence of traveler's diarrhea
Time frame: 3 weeks
Number and consistency of stools (normal, soft or unformed)
Time frame: 3 weeks
Duration of traveler's diarrhea if occurred (# days)
Time frame: 3 weeks
Presence of symptoms associated with TD (cramps, nausea, fever, blood in the stools, vomiting, bloating, flatulence, visceral pain)
Time frame: 3 weeks
Need for rescue medication
Time frame: 3 weeks
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