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

This study has been withdrawn prior to enrollment.
(Change company strategy)
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A. Identifier:
First received: October 27, 2011
Last updated: July 24, 2015
Last verified: October 2011
The study's objective is to evaluate the efficacy and safety of two formulations for the prophylactic treatment of diarrhea in subjects using antibiotics.

Condition Intervention Phase
Other: Probiotic
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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."

Resource links provided by NLM:

Further study details as provided by Eurofarma Laboratorios S.A.:

Primary Outcome Measures:
  • frequency of diarrhea in subjects using antibiotics

Secondary Outcome Measures:
  • Frequency of diarrhea by severity

Enrollment: 0
Study Start Date: February 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saccharomyces boulardii capsules (200 mg). Other: Probiotic
Active Comparator: Floratil® Other: Probiotic
Experimental: Saccharomyces boulardii powder (200 mg). Other: Probiotic


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01463943

Campinas, Brazil
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
Clinica de Alergia Martti Antila
Sorocaba, 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
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
Principal Investigator: Carlos Fernando Francesconi, MD Hospital Mãe de Deus
Principal Investigator: Flavio Quillici, MD UNIGASTRO
Principal Investigator: Martti Antila, MD Clínica 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 Universitario Pedro Ernesto
Principal Investigator: Flávio Steinwurtz, MD Hospital Albert Einstein
Principal Investigator: Cyrla Zaltman, MD Hospital Universitário Clementino Fraga Filho
Principal Investigator: José Hungria Neto, MD Santa Casa de Misericórdia
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 Clínicas de Porto Alegre
Principal Investigator: Bruno Gonçalves, MD Hospital Leforte
  More Information

Responsible Party: Eurofarma Laboratorios S.A. Identifier: NCT01463943     History of Changes
Other Study ID Numbers: EF 121
Study First Received: October 27, 2011
Last Updated: July 24, 2015

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents processed this record on May 25, 2017