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

Primary Purpose

Antibiotics

Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Probiotic
Probiotic
Probiotic
Sponsored by
Eurofarma Laboratorios S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Antibiotics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • UNICAMP
  • Unigastro
  • Hospital de Clínicas da Universidade Federal do Paraná
  • Instituto de Prevenção ao Câncer do Ceará
  • Hospital das Clinicas de Porto Alegre
  • Hospital São Lucas da PUC - RS
  • Mãe de Deus Center
  • Universidade Federal de Pernambuco
  • Hospital Universitário Clementino Fraga Filho (UFRJ)
  • Hospital Universitário Pedro Ernesto
  • Pesquisare Saúde S/S Ltda
  • Clinica de Alergia Martti Antila
  • Hospital Albert Einstein
  • Hospital das Clínicas
  • Hospital Leforte
  • Hospital Maternidade Leonor Mendes de Barros
  • Santa Casa de Misericórdia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Saccharomyces boulardii capsules (200 mg).

Floratil®

Saccharomyces boulardii powder (200 mg).

Arm Description

Outcomes

Primary Outcome Measures

frequency of diarrhea in subjects using antibiotics

Secondary Outcome Measures

Frequency of diarrhea by severity

Full Information

First Posted
October 27, 2011
Last Updated
July 24, 2015
Sponsor
Eurofarma Laboratorios S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01463943
Brief Title
Non-Inferiority Trial Comparing Eurofarma's Experimental Product Saccharomyces Boulardii Versus Floratil® in the Prevention of Antibiotic-Associated Diarrhea
Acronym
ACROSS
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 Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Change company strategy
Study Start Date
February 2012 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eurofarma Laboratorios S.A.

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotics

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saccharomyces boulardii capsules (200 mg).
Arm Type
Experimental
Arm Title
Floratil®
Arm Type
Active Comparator
Arm Title
Saccharomyces boulardii powder (200 mg).
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Probiotic
Intervention Type
Other
Intervention Name(s)
Probiotic
Intervention Type
Other
Intervention Name(s)
Probiotic
Primary Outcome Measure Information:
Title
frequency of diarrhea in subjects using antibiotics
Secondary Outcome Measure Information:
Title
Frequency of diarrhea by severity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ICF signature; The subject must agree to follow the instructions and to perform study procedures and visits; Male and female subjects between 18 and 65 years old; Subjects who have scheduled a treatment or started the use of antibiotics over 24 hours ago: Exclusion Criteria: Generalized infection or bacteremia; Chronic gastrointestinal diseases (e.g., Crohn's Disease and Irritable Bowel Syndrome); Documented chronic diarrhea; Acute diarrhea episode within 24 hours prior to the start of antibiotic use. Use of tube feeding (nasogastric and nasoenteral); Immunodeficiency (radiotherapy or chemotherapy); Use of food with probiotic properties in the last 10 days;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Fernando Francesconi, MD
Organizational Affiliation
Hospital Mãe de Deus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Flavio Quillici, MD
Organizational Affiliation
UNIGASTRO
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martti Antila, MD
Organizational Affiliation
Clínica de Alergia Martti Antila
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olavo Mion, MD
Organizational Affiliation
Hospital das Clínicas - SP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José Angelo Rizzo, MD
Organizational Affiliation
Universidade Federal de Pernambuco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos Cezar Fritscher, MD
Organizational Affiliation
Hospital São Lucas da PUC - RS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronaldo Damião, MD
Organizational Affiliation
Hospital Universitario Pedro Ernesto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Flávio Steinwurtz, MD
Organizational Affiliation
Hospital Albert Einstein
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cyrla Zaltman, MD
Organizational Affiliation
Hospital Universitário Clementino Fraga Filho
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José Hungria Neto, MD
Organizational Affiliation
Santa Casa de Misericórdia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Newton Carvalho, MD
Organizational Affiliation
Hospital de Clínicas da Universidade Federal do Paraná
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julio Cesar Teixeira, MD
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreia Luisa Francisco Pez, MD
Organizational Affiliation
Pesquisare Saúde S/S Ltda
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paola Colares de Borba, MD
Organizational Affiliation
Instituto de Prevenção ao Câncer do Ceará
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cecília Roteli Martins, MD
Organizational Affiliation
HOSPITAL MATERNIDADE LEONOR MENDES DE BARROS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paulo Sérgio Viero Naud, MD
Organizational Affiliation
Hospital das Clínicas de Porto Alegre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno Gonçalves, MD
Organizational Affiliation
Hospital Leforte
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNICAMP
City
Campinas
Country
Brazil
Facility Name
Unigastro
City
Campinas
Country
Brazil
Facility Name
Hospital de Clínicas da Universidade Federal do Paraná
City
Curitiba
Country
Brazil
Facility Name
Instituto de Prevenção ao Câncer do Ceará
City
Fortaleza
Country
Brazil
Facility Name
Hospital das Clinicas de Porto Alegre
City
Por to Alegre
Country
Brazil
Facility Name
Hospital São Lucas da PUC - RS
City
Porto Alegre
Country
Brazil
Facility Name
Mãe de Deus Center
City
Porto Alegre
Country
Brazil
Facility Name
Universidade Federal de Pernambuco
City
Recife
Country
Brazil
Facility Name
Hospital Universitário Clementino Fraga Filho (UFRJ)
City
Rio de Janeiro
Country
Brazil
Facility Name
Hospital Universitário Pedro Ernesto
City
Rio de Janeiro
Country
Brazil
Facility Name
Pesquisare Saúde S/S Ltda
City
Santo André
Country
Brazil
Facility Name
Clinica de Alergia Martti Antila
City
Sorocaba
Country
Brazil
Facility Name
Hospital Albert Einstein
City
São Paulo
Country
Brazil
Facility Name
Hospital das Clínicas
City
São Paulo
Country
Brazil
Facility Name
Hospital Leforte
City
São Paulo
Country
Brazil
Facility Name
Hospital Maternidade Leonor Mendes de Barros
City
São Paulo
Country
Brazil
Facility Name
Santa Casa de Misericórdia
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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