NCT01500343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 heart-failure

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2011

Completed
Last Updated

December 28, 2011

Status Verified

December 1, 2011

Enrollment Period

1.3 years

First QC Date

December 22, 2011

Last Update Submit

December 27, 2011

Conditions

Heart Failure

Keywords

heart failureprobioticsSaccharomyces boulardiicardio-intestinal syndromegutinflammation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Analysis of cardiac remodelling

    3 months

  • Analysis of creatinine seric levels

    3 months

Study Arms (2)

Saccharomyces boulardii

EXPERIMENTAL
Drug: Saccharomyces boulardii

Placebo

PLACEBO COMPARATOR
Drug: Saccharomyces boulardii

Interventions

Saccharomyces boulardiiDRUG

1 gram per day, during 3 months

PlaceboSaccharomyces boulardii

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Class I or II (NYHA)heart failure patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitário Antonio Pedro

Niterói, Rio de Janeiro, 24033-900, Brazil

Location

MeSH Terms

Conditions

Heart FailureInflammation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Annelise C Costanza, MD

    Universidade Federal Fluminense

    PRINCIPAL INVESTIGATOR

  • Evandro T Mesquita, MD,PhD

    Universidade Federal Fluminense

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 22, 2011

First Posted

December 28, 2011

Study Start

November 1, 2008

Primary Completion

March 1, 2010

Study Completion

December 1, 2010

Last Updated

December 28, 2011

Record last verified: 2011-12

Locations

BR(1)