A Pilot Study of Probiotic Saccharomyces Boulardii Use in Chronic Heart Failure Patients. Estudo PROICA (PROICA)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Saccharomyces boulardii
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring heart failure, probiotics, Saccharomyces boulardii, cardio-intestinal syndrome, gut, inflammation
Eligibility Criteria
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
Sites / Locations
- Hospital Universitário Antonio Pedro
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Saccharomyces boulardii
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Analysis of biochemical profile (high-sensitivity C reactive protein, total leukocyte count and uric acid seric levels)
Analysis at baseline and after intervention
Secondary Outcome Measures
Analysis of cardiac remodelling
Ecocardiographic analysis of left atrial diameter and left ventricular ejection fraction at baseline and after intervention
Analysis of creatinine seric levels
Full Information
NCT ID
NCT01500343
First Posted
December 22, 2011
Last Updated
December 27, 2011
Sponsor
Universidade Federal Fluminense
1. Study Identification
Unique Protocol Identification Number
NCT01500343
Brief Title
A Pilot Study of Probiotic Saccharomyces Boulardii Use in Chronic Heart Failure Patients. Estudo PROICA
Acronym
PROICA
Official Title
A Pilot Study of Probiotic Saccharomyces Boulardii Use in Chronic Heart Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal Fluminense
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, probiotics, Saccharomyces boulardii, cardio-intestinal syndrome, gut, inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saccharomyces boulardii
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Saccharomyces boulardii
Intervention Description
1 gram per day, during 3 months
Primary Outcome Measure Information:
Title
Analysis of biochemical profile (high-sensitivity C reactive protein, total leukocyte count and uric acid seric levels)
Description
Analysis at baseline and after intervention
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Analysis of cardiac remodelling
Description
Ecocardiographic analysis of left atrial diameter and left ventricular ejection fraction at baseline and after intervention
Time Frame
3 months
Title
Analysis of creatinine seric levels
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annelise C Costanza, MD
Organizational Affiliation
Universidade Federal Fluminense
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Evandro T Mesquita, MD,PhD
Organizational Affiliation
Universidade Federal Fluminense
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitário Antonio Pedro
City
Niteroi
State/Province
Rio de Janeiro
ZIP/Postal Code
24033-900
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Probiotic Saccharomyces Boulardii Use in Chronic Heart Failure Patients. Estudo PROICA
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