A Pilot Study of Probiotic Saccharomyces Boulardii Use in Chronic Heart Failure Patients. Estudo PROICA
This study has been completed.
Sponsor:
Universidade Federal Fluminense
Information provided by (Responsible Party):
Annelise Cisari Costanza, Universidade Federal Fluminense
ClinicalTrials.gov Identifier:
NCT01500343
First received: December 22, 2011
Last updated: December 27, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure |
Drug: Saccharomyces boulardii |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Probiotic Saccharomyces Boulardii Use in Chronic Heart Failure Patients |
Resource links provided by NLM:
Further study details as provided by Universidade Federal Fluminense:
Primary Outcome Measures:
- Analysis of biochemical profile (high-sensitivity C reactive protein, total leukocyte count and uric acid seric levels) [ Time Frame: 3 months ] [ Designated as safety issue: No ]Analysis at baseline and after intervention
Secondary Outcome Measures:
- Analysis of cardiac remodelling [ Time Frame: 3 months ] [ Designated as safety issue: No ]Ecocardiographic analysis of left atrial diameter and left ventricular ejection fraction at baseline and after intervention
- Analysis of creatinine seric levels [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 20 |
| Study Start Date: | November 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Saccharomyces boulardii |
Drug: Saccharomyces boulardii
1 gram per day, during 3 months
|
| Placebo Comparator: Placebo |
Drug: Saccharomyces boulardii
1 gram per day, during 3 months
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500343
Locations
| Brazil | |
| Hospital Universitário Antonio Pedro | |
| Niteroi, Rio de Janeiro, Brazil, 24033-900 | |
Sponsors and Collaborators
Universidade Federal Fluminense
Investigators
| Principal Investigator: | Annelise C Costanza, MD | Universidade Federal Fluminense |
| Study Director: | Evandro T Mesquita, MD,PhD | Universidade Federal Fluminense |
More Information
No publications provided
| Responsible Party: | Annelise Cisari Costanza, Principal investigator, Universidade Federal Fluminense |
| ClinicalTrials.gov Identifier: | NCT01500343 History of Changes |
| Other Study ID Numbers: | UFF-Cardiologia-01 |
| Study First Received: | December 22, 2011 |
| Last Updated: | December 27, 2011 |
| Health Authority: | Brazil: Ministry of Health Brazil: National Committee of Ethics in Research |
Keywords provided by Universidade Federal Fluminense:
|
heart failure probiotics Saccharomyces boulardii |
cardio-intestinal syndrome gut inflammation |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013