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

NCT ID: NCT01500343

Last Updated: 2011-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-12-31

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.

Conditions

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Heart Failure

Keywords

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heart failure probiotics Saccharomyces boulardii cardio-intestinal syndrome gut inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Saccharomyces boulardii

Group Type EXPERIMENTAL

Saccharomyces boulardii

Intervention Type DRUG

1 gram per day, during 3 months

Placebo

Group Type PLACEBO_COMPARATOR

Saccharomyces boulardii

Intervention Type DRUG

1 gram per day, during 3 months

Interventions

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Saccharomyces boulardii

1 gram per day, during 3 months

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal Fluminense

OTHER

Sponsor Role lead

Responsible Party

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Annelise Cisari Costanza

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Annelise C Costanza, MD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal Fluminense

Evandro T Mesquita, MD,PhD

Role: STUDY_DIRECTOR

Universidade Federal Fluminense

Locations

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Hospital Universitário Antonio Pedro

Niterói, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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UFF-Cardiologia-01

Identifier Type: -

Identifier Source: org_study_id