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

NCT01463943 | Withdrawn Phase 3

• 1 other identifier: EF 121
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 17

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.

Conditions

Antibiotics

Outcome Measures

Primary Outcomes (1)

• frequency of diarrhea in subjects using antibiotics

Secondary Outcomes (1)

• Frequency of diarrhea by severity

Study Arms (3)

Saccharomyces boulardii capsules (200 mg).

EXPERIMENTAL

Other: Probiotic

Floratil®

ACTIVE COMPARATOR

Other: Probiotic

Saccharomyces boulardii powder (200 mg).

EXPERIMENTAL

Other: Probiotic

Interventions

Probiotic OTHER

Saccharomyces boulardii capsules (200 mg).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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;

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (17)

UNICAMP

Campinas, Brazil

Location

Unigastro

Campinas, Brazil

Location

Hospital de Clínicas da Universidade Federal do Paraná

Curitiba, Brazil

Location

Instituto de Prevenção ao Câncer do Ceará

Fortaleza, Brazil

Location

Hospital das Clinicas de Porto Alegre

Por to Alegre, Brazil

Location

Hospital São Lucas da PUC - RS

Porto Alegre, Brazil

Location

Mãe de Deus Center

Porto Alegre, Brazil

Location

Universidade Federal de Pernambuco

Recife, Brazil

Location

Hospital Universitário Clementino Fraga Filho (UFRJ)

Rio de Janeiro, Brazil

Location

Hospital Universitário Pedro Ernesto

Rio de Janeiro, Brazil

Location

Pesquisare Saúde S/S Ltda

Santo André, Brazil

Location

Hospital Albert Einstein

São Paulo, Brazil

Location

Hospital das Clínicas

São Paulo, Brazil

Location

Hospital Leforte

São Paulo, Brazil

Location

Hospital Maternidade Leonor Mendes de Barros

São Paulo, Brazil

Location

Santa Casa de Misericórdia

São Paulo, Brazil

Location

Clinica de Alergia Martti Antila

Sorocaba, Brazil

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: November 2, 2011
• Study Start: February 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 27, 2015

Record last verified: 2011-10

Locations

BR (17)