Trial Information
"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."
Inclusion Criteria:
1. ICF signature;
2. The subject must agree to follow the instructions and to perform study procedures and
visits;
3. Male and female subjects between 18 and 65 years old;
4. Subjects who have scheduled a treatment or started the use of antibiotics over 24
hours ago:
Exclusion Criteria:
1. Generalized infection or bacteremia;
2. Chronic gastrointestinal diseases (e.g., Crohn's Disease and Irritable Bowel
Syndrome);
3. Documented chronic diarrhea;
4. Acute diarrhea episode within 24 hours prior to the start of antibiotic use. Use of
tube feeding (nasogastric and nasoenteral);
5. Immunodeficiency (radiotherapy or chemotherapy);
6. Use of food with probiotic properties in the last 10 days;
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
frequency of diarrhea in subjects using antibiotics
Safety Issue:
No
Principal Investigator
Carlos Fernando Francesconi, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospital Mãe de Deus
Authority:
Brazil: Ethics Committee
Study ID:
EF 121
NCT ID:
NCT01463943
Start Date:
February 2012
Completion Date:
December 2012
Related Keywords: