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

Universidade Federal Fluminense

Status and phase: Completed; Phase 2

Conditions: Heart Failure

Treatments: Drug: Saccharomyces boulardii

Study type: Interventional

Funder types: Other

Identifiers

NCT01500343

UFF-Cardiologia-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Saccharomyces boulardii

Experimental group

Treatment:

Drug: Saccharomyces boulardii

Placebo

Placebo Comparator group

Treatment:

Drug: Saccharomyces boulardii