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
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 22, 2011 | ||||||||
| Last Updated Date | December 27, 2011 | ||||||||
| Start Date ICMJE | November 2008 | ||||||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01500343 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Pilot Study of Probiotic Saccharomyces Boulardii Use in Chronic Heart Failure Patients. Estudo PROICA | ||||||||
| Official Title ICMJE | A Pilot Study of Probiotic Saccharomyces Boulardii Use in Chronic Heart Failure Patients | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Heart Failure | ||||||||
| Intervention ICMJE | Drug: Saccharomyces boulardii
1 gram per day, during 3 months |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 20 | ||||||||
| Completion Date | December 2010 | ||||||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01500343 | ||||||||
| Other Study ID Numbers ICMJE | UFF-Cardiologia-01 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Annelise Cisari Costanza, Universidade Federal Fluminense | ||||||||
| Study Sponsor ICMJE | Universidade Federal Fluminense | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Universidade Federal Fluminense | ||||||||
| Verification Date | December 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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