Non-Inferiority Trial Comparing Eurofarma's Experimental Product Saccharomyces Boulardii Versus Floratil® in the Prevention of Antibiotic-Associated Diarrhea (ACROSS)
This study is not yet open for participant recruitment.
Verified October 2011 by Eurofarma Laboratorios S.A.
Sponsor:
Eurofarma Laboratorios S.A.
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
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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:
- 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;
Contacts and Locations
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 |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013