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

Antibiotics Clinical Trial

— 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."

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01463943
• Other study ID #: EF 121
• Status: Withdrawn
• Phase: Phase 3
• First received: October 27, 2011
• Last updated: July 24, 2015
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: October 2011
• Source: Eurofarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Antibiotics
• Diarrhea

Intervention

Other:
• Probiotic

• Probiotic

• Probiotic

Locations

Country	Name	City	State
Brazil	UNICAMP	Campinas
Brazil	Unigastro	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	Hospital São Lucas da PUC - RS	Porto Alegre
Brazil	Mãe de Deus Center	Porto Alegre
Brazil	Universidade Federal de Pernambuco	Recife
Brazil	Hospital Universitário Clementino Fraga Filho (UFRJ)	Rio de Janeiro
Brazil	Hospital Universitário Pedro Ernesto	Rio de Janeiro
Brazil	Pesquisare Saúde S/S Ltda	Santo André
Brazil	Hospital Albert Einstein	São Paulo
Brazil	Hospital das Clínicas	São Paulo
Brazil	Hospital Leforte	São Paulo
Brazil	Hospital Maternidade Leonor Mendes de Barros	São Paulo
Brazil	Santa Casa de Misericórdia	São Paulo
Brazil	Clinica de Alergia Martti Antila	Sorocaba

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of diarrhea in subjects using antibiotics			No
Secondary	Frequency of diarrhea by severity			Yes