Clinical trial NCT01463943: Non-Inferiority Trial Comparing Eurofarma's Experimental Product Saccharomyces Boulardii Versus Floratil® in the Prevention of Antibiotic-Associated Diarrhea
Official title: "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."
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Antibiotics
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2011-11-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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;

Primary outcomes:
measure: frequency of diarrhea in subjects using antibiotics
Secondary outcomes:
measure: Frequency of diarrhea by severity
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: UNICAMP
city: Campinas
country: Brazil
facility: Unigastro
city: Curitiba
country: Brazil
facility: Hospital de Clínicas da Universidade Federal do Paraná
city: Fortaleza
country: Brazil
facility: Instituto de Prevenção ao Câncer do Ceará
city: Por to Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUC - RS
city: Porto Alegre
country: Brazil
facility: Mãe de Deus Center
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Clementino Fraga Filho (UFRJ)
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Pedro Ernesto
city: Santo André
country: Brazil
facility: Pesquisare Saúde S/S Ltda
city: Sorocaba
country: Brazil
facility: Clinica de Alergia Martti Antila
city: São Paulo
country: Brazil
facility: Hospital Albert Einstein
city: São Paulo
country: Brazil
facility: Hospital das Clínicas
city: São Paulo
country: Brazil
facility: Hospital Leforte
city: São Paulo
country: Brazil
facility: Hospital Maternidade Leonor Mendes de Barros
city: São Paulo
country: Brazil
facility: Santa Casa de Misericórdia
Study officials:
affiliation: Hospital Mãe de Deus
name: Carlos Fernando Francesconi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNIGASTRO
name: Flavio Quillici, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica de Alergia Martti Antila
name: Martti Antila, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital das Clínicas - SP
name: Olavo Mion, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de Pernambuco
name: José Angelo Rizzo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital São Lucas da PUC - RS
name: Carlos Cezar Fritscher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Pedro Ernesto
name: Ronaldo Damião, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Albert Einstein
name: Flávio Steinwurtz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitário Clementino Fraga Filho
name: Cyrla Zaltman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Santa Casa de Misericórdia
name: José Hungria Neto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clínicas da Universidade Federal do Paraná
name: Newton Carvalho, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campinas, Brazil
name: Julio Cesar Teixeira, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pesquisare Saúde S/S Ltda
name: Andreia Luisa Francisco Pez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Prevenção ao Câncer do Ceará
name: Paola Colares de Borba, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HOSPITAL MATERNIDADE LEONOR MENDES DE BARROS
name: Cecília Roteli Martins, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital das Clínicas de Porto Alegre
name: Paulo Sérgio Viero Naud, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Leforte
name: Bruno Gonçalves, MD
role: PRINCIPAL_INVESTIGATOR
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