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

Phase 3

Withdrawn

• Conditions: Antibiotics
• Interventions: Other: Probiotic

• Registration Number: NCT01463943
• Lead Sponsor: Eurofarma Laboratorios S.A.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-10
• Study First Submitted: 2011-10-27
• Study First Submitted QC: 2011-11-01
• Study First Posted: 2011-11-02
• Study Start: 2012-02
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Last Update Submitted: 2015-07-24
• Last Update Posted: 2015-07-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saccharomyces boulardii capsules (200 mg).	Probiotic	-
Floratil®	Probiotic	-
Saccharomyces boulardii powder (200 mg).	Probiotic	-

Primary Outcome Measures

Name	Time	Method
frequency of diarrhea in subjects using antibiotics

Secondary Outcome Measures

Name	Time	Method
Frequency of diarrhea by severity

Trial Locations

Locations (17)

Mãe de Deus Center; 🇧🇷 Porto Alegre, Brazil

Pesquisare Saúde S/S Ltda; 🇧🇷 Santo André, Brazil

Hospital Universitário Clementino Fraga Filho (UFRJ); 🇧🇷 Rio de Janeiro, Brazil

Hospital Albert Einstein; 🇧🇷 São Paulo, Brazil

Hospital São Lucas da PUC - RS; 🇧🇷 Porto Alegre, Brazil

Hospital das Clínicas; 🇧🇷 São Paulo, Brazil

UNICAMP; 🇧🇷 Campinas, Brazil

Universidade Federal de Pernambuco; 🇧🇷 Recife, Brazil

Hospital Universitário Pedro Ernesto; 🇧🇷 Rio de Janeiro, Brazil

Hospital Leforte; 🇧🇷 São Paulo, Brazil

Santa Casa de Misericórdia; 🇧🇷 São Paulo, Brazil

Clinica de Alergia Martti Antila; 🇧🇷 Sorocaba, Brazil

Hospital de Clínicas da Universidade Federal do Paraná; 🇧🇷 Curitiba, Brazil

Hospital das Clinicas de Porto Alegre; 🇧🇷 Por to Alegre, Brazil

Unigastro; 🇧🇷 Campinas, Brazil

Instituto de Prevenção ao Câncer do Ceará; 🇧🇷 Fortaleza, Brazil

Hospital Maternidade Leonor Mendes de Barros; 🇧🇷 São Paulo, Brazil