Status:
WITHDRAWN
Non-Inferiority Trial Comparing Eurofarma's Experimental Product Saccharomyces Boulardii Versus Floratil® in the Prevention of Antibiotic-Associated Diarrhea
Lead Sponsor:
Eurofarma Laboratorios S.A.
Conditions:
Antibiotics
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01463943
Start Date
February 1 2012
End Date
December 1 2012
Last Update
July 27 2015
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
UNICAMP
Campinas, Brazil
2
Unigastro
Campinas, Brazil
3
Hospital de Clínicas da Universidade Federal do Paraná
Curitiba, Brazil
4
Instituto de Prevenção ao Câncer do Ceará
Fortaleza, Brazil