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

Eurofarma

Status and phase: Withdrawn; Phase 3

Conditions: Antibiotics

Treatments: Other: Probiotic

Study type: Interventional

Funder types: Industry

Identifiers

NCT01463943

EF 121

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Saccharomyces boulardii capsules (200 mg).

Experimental group

Treatment:

Other: Probiotic

Other: Probiotic

Other: Probiotic

Floratil®

Active Comparator group

Treatment:

Other: Probiotic

Other: Probiotic

Other: Probiotic

Saccharomyces boulardii powder (200 mg).

Experimental group

Treatment:

Other: Probiotic

Other: Probiotic

Other: Probiotic