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

This study has been completed.
Information provided by (Responsible Party):
Annelise Cisari Costanza, Universidade Federal Fluminense Identifier:
First received: December 22, 2011
Last updated: December 27, 2011
Last verified: December 2011
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]
    Analysis at baseline and after intervention

Secondary Outcome Measures:
  • Analysis of cardiac remodelling [ Time Frame: 3 months ]
    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 ]

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01500343

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

Responsible Party: Annelise Cisari Costanza, Principal investigator, Universidade Federal Fluminense Identifier: NCT01500343     History of Changes
Other Study ID Numbers: UFF-Cardiologia-01
Study First Received: December 22, 2011
Last Updated: December 27, 2011

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on April 27, 2017