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

NCT ID: NCT01463943

Last Updated: 2015-07-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-12-31

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.

Conditions

Antibiotics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Saccharomyces boulardii capsules (200 mg).

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: OTHER

Floratil®

Group Type: ACTIVE_COMPARATOR

Probiotic

Intervention Type: OTHER

Saccharomyces boulardii powder (200 mg).

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: OTHER

Interventions

Probiotic

Intervention Type: OTHER

Probiotic

Intervention Type: OTHER

Probiotic

Intervention Type: OTHER

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Fernando Francesconi, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Mãe de Deus

Flavio Quillici, MD

Role: PRINCIPAL_INVESTIGATOR

UNIGASTRO

Martti Antila, MD

Role: PRINCIPAL_INVESTIGATOR

Clínica de Alergia Martti Antila

Olavo Mion, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital das Clínicas - SP

José Angelo Rizzo, MD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Pernambuco

Carlos Cezar Fritscher, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital São Lucas da PUC - RS

Ronaldo Damião, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Pedro Ernesto

Flávio Steinwurtz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Albert Einstein

Cyrla Zaltman, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitário Clementino Fraga Filho

José Hungria Neto, MD

Role: PRINCIPAL_INVESTIGATOR

Santa Casa de Misericórdia

Newton Carvalho, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas da Universidade Federal do Paraná

Julio Cesar Teixeira, MD

Role: PRINCIPAL_INVESTIGATOR

University of Campinas, Brazil

Andreia Luisa Francisco Pez, MD

Role: PRINCIPAL_INVESTIGATOR

Pesquisare Saúde S/S Ltda

Paola Colares de Borba, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Prevenção ao Câncer do Ceará

Cecília Roteli Martins, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL MATERNIDADE LEONOR MENDES DE BARROS

Paulo Sérgio Viero Naud, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital das Clínicas de Porto Alegre

Bruno Gonçalves, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Leforte

Locations

UNICAMP

Campinas, , Brazil

Unigastro

Campinas, , Brazil

Hospital de Clínicas da Universidade Federal do Paraná

Curitiba, , Brazil

Instituto de Prevenção ao Câncer do Ceará

Fortaleza, , Brazil

Hospital das Clinicas de Porto Alegre

Por to Alegre, , Brazil

Hospital São Lucas da PUC - RS

Porto Alegre, , Brazil

Mãe de Deus Center

Porto Alegre, , Brazil

Universidade Federal de Pernambuco

Recife, , Brazil

Hospital Universitário Clementino Fraga Filho (UFRJ)

Rio de Janeiro, , Brazil

Hospital Universitário Pedro Ernesto

Rio de Janeiro, , Brazil

Pesquisare Saúde S/S Ltda

Santo André, , Brazil

Hospital Albert Einstein

São Paulo, , Brazil

Hospital das Clínicas

São Paulo, , Brazil

Hospital Leforte

São Paulo, , Brazil

Hospital Maternidade Leonor Mendes de Barros

São Paulo, , Brazil

Santa Casa de Misericórdia

São Paulo, , Brazil

Clinica de Alergia Martti Antila

Sorocaba, , Brazil

Countries

Brazil

Other Identifiers

EF 121

Identifier Type: -

Identifier Source: org_study_id