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

December 27, 2011 updated by: Annelise Cisari Costanza, Universidade Federal Fluminense

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 3 months
Analysis at baseline and after intervention
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFF-Cardiologia-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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