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

Sponsor
Eurofarma Laboratorios S.A. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01463943
Collaborator
(none)
0
Enrollment
17
Locations
3
Arms
10
Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Probiotic
  • Other: Probiotic
  • Other: Probiotic
 Phase 3

Study Design

Study Type:
Interventional
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 :
Feb 1, 2012
Anticipated Primary Completion Date :
Nov 1, 2012
Anticipated Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Saccharomyces boulardii capsules (200 mg).

Other: Probiotic
Active Comparator: Floratil®

Other: Probiotic
Experimental: Saccharomyces boulardii powder (200 mg).

Other: Probiotic

Outcome Measures

Primary Outcome Measures

  1. frequency of diarrhea in subjects using antibiotics []

Secondary Outcome Measures

  1. Frequency of diarrhea by severity []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
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

Locations

Site City State Country Postal Code
1 UNICAMP Campinas Brazil
2 Unigastro Campinas Brazil
3 Hospital de Clínicas da Universidade Federal do Paraná Curitiba Brazil
4 Instituto de Prevenção ao Câncer do Ceará Fortaleza Brazil
5 Hospital das Clinicas de Porto Alegre Por to Alegre Brazil
6 Hospital São Lucas da PUC - RS Porto Alegre Brazil
7 Mãe de Deus Center Porto Alegre Brazil
8 Universidade Federal de Pernambuco Recife Brazil
9 Hospital Universitário Clementino Fraga Filho (UFRJ) Rio de Janeiro Brazil
10 Hospital Universitário Pedro Ernesto Rio de Janeiro Brazil
11 Pesquisare Saúde S/S Ltda Santo André Brazil
12 Clinica de Alergia Martti Antila Sorocaba Brazil
13 Hospital Albert Einstein São Paulo Brazil
14 Hospital das Clínicas São Paulo Brazil
15 Hospital Leforte São Paulo Brazil
16 Hospital Maternidade Leonor Mendes de Barros São Paulo Brazil
17 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01463943
Other Study ID Numbers:
  • EF 121
First Posted:
Nov 2, 2011
Last Update Posted:
Jul 27, 2015
Last Verified:
Oct 1, 2011
Additional relevant MeSH terms:
Diarrhea

Study Results

No Results Posted as of Jul 27, 2015