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

"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."

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

Study Overview

• Status: Withdrawn
• Conditions: Antibiotics
• Intervention / Treatment: Other: Probiotic

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Campinas, Brazil
    • Unicamp
  • Campinas, Brazil
    • Unigastro
  • Curitiba, Brazil
    • Hospital de Clínicas da Universidade Federal do Paraná
  • Fortaleza, Brazil
    • Instituto de Prevenção ao Câncer do Ceará
  • Por to Alegre, Brazil
    • Hospital das Clinicas de Porto Alegre
  • Porto Alegre, Brazil
    • Hospital São Lucas da PUC - RS
  • Porto Alegre, Brazil
    • Mãe de Deus Center
  • Recife, Brazil
    • Universidade Federal de Pernambuco
  • Rio de Janeiro, Brazil
    • Hospital Universitário Pedro Ernesto
  • Rio de Janeiro, Brazil
    • Hospital Universitário Clementino Fraga Filho (UFRJ)
  • Santo André, Brazil
    • Pesquisare Saúde S/S Ltda
  • Sorocaba, Brazil
    • Clinica de Alergia Martti Antila
  • São Paulo, Brazil
    • Hospital Maternidade Leonor Mendes de Barros
  • São Paulo, Brazil
    • Hospital Leforte
  • São Paulo, Brazil
    • Hospital Albert Einstein
  • São Paulo, Brazil
    • Hospital das Clinicas
  • São Paulo, Brazil
    • Santa Casa de Misericordia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Saccharomyces boulardii capsules (200 mg).	Other: Probiotic
Active Comparator: Floratil®	Other: Probiotic
Experimental: Saccharomyces boulardii powder (200 mg).	Other: Probiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
frequency of diarrhea in subjects using antibiotics

Secondary Outcome Measures

Outcome Measure
Frequency of diarrhea by severity

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.
• Investigators: Principal Investigator: Carlos Fernando Francesconi, MD, Hospital Mae de Deus; Principal Investigator: Flavio Quillici, MD, Unigastro; Principal Investigator: Martti Antila, MD, Clinica de Alergia Martti Antila; Principal Investigator: Olavo Mion, MD, Hospital das Clínicas - SP; Principal Investigator: José Angelo Rizzo, MD, Universidade Federal de Pernambuco; Principal Investigator: Carlos Cezar Fritscher, MD, Hospital São Lucas da PUC - RS; Principal Investigator: Ronaldo Damião, MD, Hospital Universitário Pedro Ernesto; Principal Investigator: Flávio Steinwurtz, MD, Hospital Albert Einstein; Principal Investigator: Cyrla Zaltman, MD, Hospital Universitario Clementino Fraga Filho; Principal Investigator: José Hungria Neto, MD, Santa Casa de Misericordia; Principal Investigator: Newton Carvalho, MD, Hospital de Clínicas da Universidade Federal do Paraná; Principal Investigator: Julio Cesar Teixeira, MD, University of Campinas, Brazil; Principal Investigator: Andreia Luisa Francisco Pez, MD, Pesquisare Saúde S/S Ltda; Principal Investigator: Paola Colares de Borba, MD, Instituto de Prevenção ao Câncer do Ceará; Principal Investigator: Cecília Roteli Martins, MD, Hospital Maternidade Leonor Mendes de Barros; Principal Investigator: Paulo Sérgio Viero Naud, MD, Hospital das Clinicas de Porto Alegre; Principal Investigator: Bruno Gonçalves, MD, Hospital Leforte

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): November 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: October 27, 2011
• First Submitted That Met QC Criteria: November 1, 2011
• First Posted (Estimate): November 2, 2011

Study Record Updates

• Last Update Posted (Estimate): July 27, 2015
• Last Update Submitted That Met QC Criteria: July 24, 2015
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: EF 121