We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01463943
Recruitment Status : Withdrawn (Change company strategy)
First Posted : November 2, 2011
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.

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.

Condition or disease Intervention/treatment Phase
Antibiotics Other: Probiotic Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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."
Study Start Date : February 2012
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea
U.S. FDA Resources

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



Primary Outcome Measures :
  1. frequency of diarrhea in subjects using antibiotics

Secondary Outcome Measures :
  1. Frequency of diarrhea by severity


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463943


Locations
Brazil
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
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.
Investigators
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

Responsible Party: Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier: NCT01463943     History of Changes
Other Study ID Numbers: EF 121
First Posted: November 2, 2011    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: October 2011

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents