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"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."


Phase 3
18 Years
65 Years
Not Enrolling
Both
Antibiotics

Thank you

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:

  • Antibiotics
  • Diarrhea

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