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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Saccharomyces boulardii


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saccharomyces boulardii<br> | Drug: Saccharomyces boulardii<br>* 1 gram per day, during 3 months<br>|
| Placebo Comparator: Placebo<br> | Drug: Saccharomyces boulardii<br>* 1 gram per day, during 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, probiotics, Saccharomyces boulardii, cardio-intestinal syndrome, gut, inflammation