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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Annelise Cisari Costanza, Universidade Federal Fluminense
ClinicalTrials.gov Identifier:
NCT01500343
First received: December 22, 2011
Last updated: December 27, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Heart Failure
Drug: Saccharomyces boulardii
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study of Probiotic Saccharomyces Boulardii Use in Chronic Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by Universidade Federal Fluminense:

Primary Outcome Measures:
  • Analysis of biochemical profile (high-sensitivity C reactive protein, total leukocyte count and uric acid seric levels) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Analysis at baseline and after intervention


Secondary Outcome Measures:
  • Analysis of cardiac remodelling [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Ecocardiographic analysis of left atrial diameter and left ventricular ejection fraction at baseline and after intervention

  • Analysis of creatinine seric levels [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: November 2008
Study Completion Date: December 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saccharomyces boulardii Drug: Saccharomyces boulardii
1 gram per day, during 3 months
Placebo Comparator: Placebo Drug: Saccharomyces boulardii
1 gram per day, during 3 months

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500343

Locations
Brazil
Hospital Universitário Antonio Pedro
Niteroi, Rio de Janeiro, Brazil, 24033-900
Sponsors and Collaborators
Universidade Federal Fluminense
Investigators
Principal Investigator: Annelise C Costanza, MD Universidade Federal Fluminense
Study Director: Evandro T Mesquita, MD,PhD Universidade Federal Fluminense
  More Information

No publications provided

Responsible Party: Annelise Cisari Costanza, Principal investigator, Universidade Federal Fluminense
ClinicalTrials.gov Identifier: NCT01500343     History of Changes
Other Study ID Numbers: UFF-Cardiologia-01
Study First Received: December 22, 2011
Last Updated: December 27, 2011
Health Authority: Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal Fluminense:
heart failure
probiotics
Saccharomyces boulardii
cardio-intestinal syndrome
gut
inflammation

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 20, 2014