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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01500343
First Posted: December 28, 2011
Last Update Posted: December 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Annelise Cisari Costanza, Universidade Federal Fluminense
  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
Intervention Model: Parallel Assignment
Masking: Triple (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 Annelise Cisari Costanza, 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Annelise Cisari Costanza, Principal investigator, Universidade Federal Fluminense
ClinicalTrials.gov Identifier: NCT01500343     History of Changes
Other Study ID Numbers: UFF-Cardiologia-01
First Submitted: December 22, 2011
First Posted: December 28, 2011
Last Update Posted: December 28, 2011
Last Verified: December 2011

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases