Heart FailurePhase 2PROICANCT01500343
A Pilot Study of Probiotic Saccharomyces Boulardii Use in Chronic Heart Failure Patients. Estudo PROICA
A Phase 2 study testing Saccharomyces boulardii in people with Heart Failure, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Saccharomyces boulardii
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2008to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Class I or II (NYHA)heart failure patients
Who cannot join
- Corticosteroid use within 30 days
- NSAID use within 30 days
- Antibiotic use within 30 days
- Acute infections
- Inflammatory diseases
- Autoimmune diseases
Show all 9Show fewer
- Cancer
- Intestinal diseases
- Chronic renal failure
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitário Antonio Pedro
Niterói, Rio de Janeiro, 24033-900
About this study
Official title: A Pilot Study of Probiotic Saccharomyces Boulardii Use in Chronic Heart Failure Patients
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Saccharomyces boulardii
- Keywords
- heart failure, probiotics, Saccharomyces boulardii, cardio-intestinal syndrome, gut, inflammation
- Medical subject headings
- Heart Failure, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saccharomyces boulardiiDrug
1 gram per day, during 3 months
| Study group | Role | What they receive |
|---|---|---|
| Saccharomyces boulardii | Experimental | Not described Receives: Drug: Saccharomyces boulardii |
| Placebo | Placebo comparator | Not described Receives: Drug: Saccharomyces boulardii |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of biochemical profile (high-sensitivity C reactive protein, total leukocyte count and uric acid seric levels)
Analysis at baseline and after intervention
Measured: 3 months
Secondary outcomes (2)
Analysis of cardiac remodelling
Ecocardiographic analysis of left atrial diameter and left ventricular ejection fraction at baseline and after intervention
Measured: 3 months
Analysis of creatinine seric levels
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study startNov 2008
- Primary completionMar 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annelise Cisari Costanza, Universidade Federal Fluminense
- Investigators
- Annelise C Costanza, MD, Principal investigator, Universidade Federal FluminenseEvandro T Mesquita, MD,PhD, Study director, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500343
- Sponsor's protocol ID
- UFF-Cardiologia-01
- Acronym
- PROICA
- Status last verified
- Dec 2011
- First submitted
- 22 Dec 2011
- Last updated
- 28 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Probiotic Saccharomyces Boulardii Use in Chronic Heart Failure Patients
- ClinicalTrials.gov ID
- NCT01500343
- Acronym / sponsor ID
- PROICA / UFF-Cardiologia-01
- Conditions
- Heart Failure
- Keywords
- heart failure, probiotics, Saccharomyces boulardii, cardio-intestinal syndrome, gut, inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saccharomyces boulardii | Experimental | Drug: Saccharomyces boulardii |
| Placebo | Placebo comparator | Drug: Saccharomyces boulardii |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Class I or II (NYHA)heart failure patients
Key exclusion criteria (9 listed)
- Corticosteroid use within 30 days
- NSAID use within 30 days
- Antibiotic use within 30 days
- Acute infections
- Inflammatory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saccharomyces boulardii1 gram per day, during 3 months | Drug | Placebo, Saccharomyces boulardii |
Primary outcome
Analysis of biochemical profile (high-sensitivity C reactive protein, total leukocyte count and uric acid seric levels)
Time frame: 3 months
Analysis at baseline and after intervention
2 secondary outcomes
Analysis of cardiac remodelling
Time frame: 3 months
Analysis of creatinine seric levels
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annelise C Costanza, MD principal investigator
Universidade Federal Fluminense
Evandro T Mesquita, MD,PhD study director
Universidade Federal Fluminense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Saccharomyces boulardii in people with Heart Failure, run by Universidade Federal Fluminense at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of biochemical profile (high-sensitivity C reactive protein, total leukocyte count and uric acid seric levels) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2011.