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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01500343

Acronym

PROICA

Enrollment

Registered

2011-12-28

Start date

2008-11-30

Completion date

2010-12-31

Last updated

2011-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

heart failure, probiotics, Saccharomyces boulardii, cardio-intestinal syndrome, gut, inflammation

Brief summary

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.

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.

Interventions

DRUGSaccharomyces boulardii

1 gram per day, during 3 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Analysis of biochemical profile (high-sensitivity C reactive protein, total leukocyte count and uric acid seric levels)	3 months	Analysis at baseline and after intervention

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026