A Pilot Study of Probiotic Saccharomyces Boulardii Use in Chronic Heart Failure Patients. Estudo PROICA

Heart Failure Clinical Trial

— PROICA  

Official title:

A Pilot Study of Probiotic Saccharomyces Boulardii Use in Chronic Heart Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500343
• Other study ID #: UFF-Cardiologia-01
• Status: Completed
• Phase: Phase 2
• First received: December 22, 2011
• Last updated: December 27, 2011
• Start date: November 2008
• Est. completion date: December 2010

Study information

• Verified date: December 2011
• Source: Universidade Federal Fluminense
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the feasibility, safety and effects in inflammatory response of the therapy with a probiotic agent, the yeast Saccharomyces boulardii (SB), in chronic heart failure patients.

Description:

A cardiointestinal syndrome has been described in heart failure patients, with morphologic and functional intestinal disorders, increased enteropathogenic bacteria concentration, bacterial translocation and inflammatory activation, thus contributing for clinical worsening and progression of the disease.

In clinical practice, probiotics has been used in several different conditions, as inflammatory bowel diseases, acute and antibiotic-associated diarrhea, food allergies, and cancer, showing benefits in inflammation and reducing bacterial translocation. However, the use of probiotics in heart failure has never been described.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Class I or II (NYHA)heart failure patients

Exclusion Criteria:

• Corticosteroid use within 30 days

• NSAID use within 30 days

• Antibiotic use within 30 days

• Acute infections

• Inflammatory diseases

• Autoimmune diseases

• Cancer

• Intestinal diseases

• Chronic renal failure

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Saccharomyces boulardii
1 gram per day, during 3 months

Locations

Country	Name	City	State
Brazil	Hospital Universitário Antonio Pedro	Niteroi	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of biochemical profile (high-sensitivity C reactive protein, total leukocyte count and uric acid seric levels)	Analysis at baseline and after intervention	3 months	No
Secondary	Analysis of cardiac remodelling	Ecocardiographic analysis of left atrial diameter and left ventricular ejection fraction at baseline and after intervention	3 months	No
Secondary	Analysis of creatinine seric levels		3 months	Yes