Trial record 4 of 334 for:    Open Studies | "Anti-Bacterial Agents"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Eurofarma Laboratorios S.A..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01463943
First received: October 27, 2011
Last updated: November 1, 2011
Last verified: October 2011
  Purpose

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
Antibiotics
Other: Probiotic
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of diarrhea by severity [ Designated as safety issue: Yes ]

Estimated Enrollment: 1053
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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;
  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 ClinicalTrials.gov identifier: NCT01463943

Contacts
Contact: Marta Machado, MD +55 51 3336 4243 mbrenner.voy@terra.com.br

Locations
Brazil
Unigastro Not yet recruiting
Campinas, Brazil
Contact: Flavio Quillici, MD         
Principal Investigator: Flavio Quillici, MD         
UNICAMP
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
Mãe de Deus Center Not yet recruiting
Porto Alegre, Brazil
Contact: Carlos Fernando Francesconi, MD         
Principal Investigator: Carlos Fernando Francesconi         
Hospital São Lucas da PUC - RS
Porto Alegre, Brazil
Universidade Federal de Pernambuco
Recife, Brazil
Hospital Universitário Pedro Ernesto
Rio de Janeiro, Brazil
Hospital Universitário Clementino Fraga Filho (UFRJ)
Rio de Janeiro, Brazil
Pesquisare Saúde S/S Ltda
Santo André, Brazil
Clinica de Alergia Martti Antila Not yet recruiting
Sorocaba, Brazil
Contact: Martti Antila, MD         
Principal Investigator: Martti Antila, MD         
Hospital Leforte
São Paulo, Brazil
Hospital das Clínicas
São Paulo, Brazil
Hospital Maternidade Leonor Mendes de Barros
São Paulo, Brazil
Hospital Albert Einstein
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 Universitário 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

No publications provided

Responsible Party: Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier: NCT01463943     History of Changes
Other Study ID Numbers: EF 121
Study First Received: October 27, 2011
Last Updated: November 1, 2011
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 28, 2014