NCT01500343

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Universidade Federal Fluminense · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Saccharomyces boulardii	1 gram per day, during 3 months

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-03-01
• Completion: 2010-12-01
• First posted: 2011-12-28
• Last updated: 2011-12-28

Locations

1 site across 1 country: Brazil