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Probiotics and the Prevention of Traveler's Diarrhea

NCT01005849 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2012-01-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Sprim Advanced Life Sciences

    collaborator OTHER

  • Lallemand SAS

    lead INDUSTRY

Principal Investigators

  • Mirella Pontello, Prof. · University of Milan, Milan, Italy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01005849 on ClinicalTrials.gov