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

Phase 2

Completed

• Conditions: Heart Failure
• Interventions: Drug: Saccharomyces boulardii

• Registration Number: NCT01500343
• Lead Sponsor: Universidade Federal Fluminense

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2010-03
• Study Completion: 2010-12
• Status Verified: 2011-12
• Study First Submitted: 2011-12-22
• Study First Submitted QC: 2011-12-27
• Last Update Submitted: 2011-12-27
• Study First Posted: 2011-12-28
• Last Update Posted: 2011-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saccharomyces boulardii	Saccharomyces boulardii	-
Placebo	Saccharomyces boulardii	-

Primary Outcome Measures

Name	Time	Method
Analysis of biochemical profile (high-sensitivity C reactive protein, total leukocyte count and uric acid seric levels)	3 months	Analysis at baseline and after intervention

Secondary Outcome Measures

Name	Time	Method
Analysis of cardiac remodelling	3 months	Ecocardiographic analysis of left atrial diameter and left ventricular ejection fraction at baseline and after intervention
Analysis of creatinine seric levels	3 months

Trial Locations

Locations (1)

Hospital Universitário Antonio Pedro; 🇧🇷 Niteroi, Rio de Janeiro, Brazil