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

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.

Conditions

• Antibiotics

Interventions

OTHER

Probiotic

OTHER

Probiotic

OTHER

Probiotic

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.

  lead INDUSTRY

Principal Investigators

• Carlos Fernando Francesconi, MD · Hospital Mãe de Deus

• Flavio Quillici, MD · UNIGASTRO

• Martti Antila, MD · Clínica de Alergia Martti Antila

• Olavo Mion, MD · Hospital das Clínicas - SP

• José Angelo Rizzo, MD · Universidade Federal de Pernambuco

• Carlos Cezar Fritscher, MD · Hospital São Lucas da PUC - RS

• Ronaldo Damião, MD · Hospital Universitario Pedro Ernesto

• Flávio Steinwurtz, MD · Hospital Albert Einstein

• Cyrla Zaltman, MD · Hospital Universitário Clementino Fraga Filho

• José Hungria Neto, MD · Santa Casa de Misericórdia

• Newton Carvalho, MD · Hospital de Clínicas da Universidade Federal do Paraná

• Julio Cesar Teixeira, MD · University of Campinas, Brazil

• Andreia Luisa Francisco Pez, MD · Pesquisare Saúde S/S Ltda

• Paola Colares de Borba, MD · Instituto de Prevenção ao Câncer do Ceará

• Cecília Roteli Martins, MD · HOSPITAL MATERNIDADE LEONOR MENDES DE BARROS

• Paulo Sérgio Viero Naud, MD · Hospital das Clínicas de Porto Alegre

• Bruno Gonçalves, MD · Hospital Leforte

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2012-11-30

Completion

2012-12-31

Countries

• Brazil

Study Locations