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

Last updated: July 24, 2015
Sponsor: Eurofarma Laboratorios S.A.
Overall Status: Trial Not Available

Phase

3

Condition

Colic

Hyponatremia

Stomach Discomfort

Treatment

N/A

Clinical Study ID

NCT01463943
EF 121
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ICF signature;

  2. The subject must agree to follow the instructions and to perform study procedures andvisits;

  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 24hours ago:

Exclusion

Exclusion Criteria:

  1. Generalized infection or bacteremia;

  2. Chronic gastrointestinal diseases (e.g., Crohn's Disease and Irritable BowelSyndrome);

  3. Documented chronic diarrhea;

  4. Acute diarrhea episode within 24 hours prior to the start of antibiotic use. Use oftube feeding (nasogastric and nasoenteral);

  5. Immunodeficiency (radiotherapy or chemotherapy);

  6. Use of food with probiotic properties in the last 10 days;

Study Design

Study Start date:
February 01, 2012
Estimated Completion Date:
December 31, 2012

Connect with a study center

  • UNICAMP

    Campinas,
    Brazil

    Site Not Available

  • Unigastro

    Campinas,
    Brazil

    Site Not Available

  • Hospital de Clínicas da Universidade Federal do Paraná

    Curitiba,
    Brazil

    Site Not Available

  • Instituto de Prevenção ao Câncer do Ceará

    Fortaleza,
    Brazil

    Site Not Available

  • Hospital das Clinicas de Porto Alegre

    Por to Alegre,
    Brazil

    Site Not Available

  • Hospital São Lucas da PUC - RS

    Porto Alegre,
    Brazil

    Site Not Available

  • Mãe de Deus Center

    Porto Alegre,
    Brazil

    Site Not Available

  • Universidade Federal de Pernambuco

    Recife,
    Brazil

    Site Not Available

  • Hospital Universitário Clementino Fraga Filho (UFRJ)

    Rio de Janeiro,
    Brazil

    Site Not Available

  • Hospital Universitário Pedro Ernesto

    Rio de Janeiro,
    Brazil

    Site Not Available

  • Pesquisare Saúde S/S Ltda

    Santo André,
    Brazil

    Site Not Available

  • Pesquisare Saúde S/S Ltda

    Santo André,
    Brazil

    Site Not Available

  • Clinica de Alergia Martti Antila

    Sorocaba,
    Brazil

    Site Not Available

  • Hospital das Clínicas

    São Paulo,
    Brazil

    Site Not Available

  • Hospital Albert Einstein

    São Paulo,
    Brazil

    Site Not Available

  • Hospital Leforte

    São Paulo,
    Brazil

    Site Not Available

  • Hospital Maternidade Leonor Mendes de Barros

    São Paulo,
    Brazil

    Site Not Available

  • Hospital das Clínicas

    São Paulo,
    Brazil

    Site Not Available

  • Santa Casa de Misericórdia

    São Paulo,
    Brazil

    Site Not Available

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