A Pilot Study of Probiotic Saccharomyces Boulardii Use in... | NCT01500343

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

NCT01500343

Sponsor

Universidade Federal Fluminense

Status

Completed

Last Update Posted

Dec 28, 2011Estimated

Enrollment

20Actual

Phase

Phase 2

Conditions

Heart Failure

Interventions

Saccharomyces boulardii

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Mar 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Dec 22, 2011

First Submission Date that Met QC Criteria

Dec 27, 2011

First Posted Date

Dec 28, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 27, 2011

Last Update Posted Date

Dec 28, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Annelise Cisari Costanza, Principal investigator, Universidade Federal FluminensePrincipal Investigator

Lead Sponsor

Universidade Federal FluminenseOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Saccharomyces boulardii	Experimental		Drug: Saccharomyces boulardii
Placebo	Placebo Comparator		Drug: Saccharomyces boulardii

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Saccharomyces boulardii	Drug	1 gram per day, during 3 months	Placebo Saccharomyces boulardii

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Analysis of cardiac remodelling	Ecocardiographic analysis of left atrial diameter and left ventricular ejection fraction at baseline and after intervention	3 months
Analysis of creatinine seric levels

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Annelise C Costanza, MD	Universidade Federal Fluminense	Principal Investigator
Evandro T Mesquita, MD,PhD	Universidade Federal Fluminense	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitário Antonio Pedro		Niterói	Rio de Janeiro	24033-900	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D007249	Inflammation

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided