"An Open-Label, Non-Inferiority, Phase III Trial Comparing Eurofarma's Experimental Product Saccharomyces Boulardii Versus Floratil® (S. Boulardii - Merck) in the Prevention of Antibiotic-Associated Diarrhea."

Eurofarma Laboratorios S.A.17 sites in 1 countryFebruary 2012

ConditionsAntibiotics

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Antibiotics
Sponsor: Eurofarma Laboratorios S.A.
Locations: 17
Primary Endpoint: frequency of diarrhea in subjects using antibiotics
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study's objective is to evaluate the efficacy and safety of two formulations for the prophylactic treatment of diarrhea in subjects using antibiotics.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

December 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eurofarma Laboratorios S.A.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•ICF signature;
•The subject must agree to follow the instructions and to perform study procedures and visits;
•Male and female subjects between 18 and 65 years old;
•Subjects who have scheduled a treatment or started the use of antibiotics over 24 hours ago:

Exclusion Criteria

•Generalized infection or bacteremia;
•Chronic gastrointestinal diseases (e.g., Crohn's Disease and Irritable Bowel Syndrome);
•Documented chronic diarrhea;
•Acute diarrhea episode within 24 hours prior to the start of antibiotic use. Use of tube feeding (nasogastric and nasoenteral);
•Immunodeficiency (radiotherapy or chemotherapy);
•Use of food with probiotic properties in the last 10 days;