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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Saccharomyces boulardii

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro
    • Niteroi, Rio de Janeiro, Brazil, 24033-900
      • Hospital Universitario Antonio Pedro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Saccharomyces boulardii; 1 gram per day, during 3 months
EXPERIMENTAL: Saccharomyces boulardii	Drug: Saccharomyces boulardii; 1 gram per day, during 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of cardiac remodelling	Ecocardiographic analysis of left atrial diameter and left ventricular ejection fraction at baseline and after intervention	3 months
Analysis of creatinine seric levels		3 months

Collaborators and Investigators

• Sponsor: Universidade Federal Fluminense
• Investigators: Principal Investigator: Annelise C Costanza, MD, Universidade Federal Fluminense; Study Director: Evandro T Mesquita, MD,PhD, Universidade Federal Fluminense

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (ACTUAL): March 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: December 22, 2011
• First Submitted That Met QC Criteria: December 27, 2011
• First Posted (ESTIMATE): December 28, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 28, 2011
• Last Update Submitted That Met QC Criteria: December 27, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: probiotics; heart failure; inflammation; Saccharomyces boulardii; gut; cardio-intestinal syndrome
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: UFF-Cardiologia-01