NCT01005849

Probiotics and the Prevention of Traveler's Diarrhea

A Parallel, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Probiotic Formula in the Prevention of Traveler's Diarrhea

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Lallemand SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Travelers' Diarrhea

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Protecflor	1 Capsule to be taken once a day during the entire study period
DIETARY_SUPPLEMENT	Placebo	1 Capsule to be taken once a day during the entire study period

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2009-11-02
• Last updated: 2012-01-19

Locations

1 site across 1 country: Italy