Non-Inferiority Trial Comparing Eurofarma's Experimental Product Saccharomyces Boulardii Versus Floratil® in the Prevention of Antibiotic-Associated Diarrhea

"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."

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

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;