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Completed

NCT Number: NCT01500343

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitário Antonio Pedro

Niterói, Rio de Janeiro, 24033-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saccharomyces boulardii

Drug

1 gram per day, during 3 months

Primary outcomes

  1. 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 outcomes

  1. Analysis of cardiac remodelling

    Time frame: 3 months

    Ecocardiographic analysis of left atrial diameter and left ventricular ejection fraction at baseline and after intervention

  2. Analysis of creatinine seric levels

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Universidade Federal Fluminense

Other

Registry information

Official study title

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

Acronym: PROICA

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 28, 2011
Registry last updated
Dec 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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