Heart FailurePROBHFNCT03968549
Probiotics and Inflammatory Status in Patients With Heart Failure
A study testing Probiotic in people with Heart Failure, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Cachexia is a very common condition in patients with advanced heart failure (HF) and is considered a predictor of mortality. Studies have been carried out in an attempt to discover the mechanisms that leads to cachexia in order to improve the therapies and the survival of these patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Nov 2018to 31 Aug 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with heart failure NYHA functional class III and IV;
- Medications optimized for at least 2 months;
- No hospitalizations for HF decompensated or acute myocardial infarction in the last 30 days;
- Have signed the Free and Informed Consent Form
Who cannot join
- Do not accept to participate in the study or do not signed the Free and Informed Consent Form
- Have used antibiotics and/or corticosteroids in the last 30 days;
- Clinical conditions that can affect the inflammatory profile such as inflammatory bowel disease, arthrosis, among others;
- Be pregnant;
- Have been submitted to a cardiac surgery in the last 6 months or other surgery in the last 3 months
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Fernando Bacal
São Paulo
Fernando Bacal, (11) 2661-5482, fbacal@uol.com.br
About this study
Official title: Study of the Importance of Intestinal Microbiota in Patients With Heart Failure - Randomized, Double-blind Study
Cachexia is a very common condition in patients with advanced heart failure (HF) and is considered a predictor of mortality. Studies have been carried out in an attempt to discover the mechanisms that leads to cachexia in order to improve the therapies and the survival of these patients. Some of these studies give the hypothesis that the gastrointestinal tract, more precisely the intestine, can collaborate with cachexia. Some of these studies suggest that, the intestinal mucosa, due to hypoperfusion, becomes more permeable to some substances, as like endotoxins, being the lipopolysaccharide (LPS) one of them. The circulating LPS can stimulate the increase of tumor necrosis alpha (TNF-alpha) further increasing the inflammation and, consequently, contributing to the worsening of prognosis. The intestinal microbiota is also affected by hypoperfusion, contributing with increase of permeability. As known, probiotics can help to maintain or recover the microbiota and maintain a healthy intestinal barrier. In view of the importance of microbiota to inflammation in the prognosis of the patients and the performance of microbiota in maintenance of intestinal barrier, this study has as primary objective to verify the influence of supplementation of the probiotic Lactobacillus acidophilus (LA) in the lowering of serum levels of TNF-alpha in the patients with HF.
Read the detailed description
The present study will be a clinical trial compounded by two parallel arms, randomized, double-blind (researcher-patient), placebo-controlled, with patients with heart failure (HF), functional class according the New York Heart Association (NYHA) III and IV. It will be included 58 patients, 29 will receive probiotics and 29 will receive placebo. These patients will be accompanied during 6 months and should take one capsule every day during the study. In the beginning of the study and at the end, venous blood sample will be collected of each patient for laboratory measurement of TNF alpha, interleukins 1,6 and 10, LPS, B-type natriuretic peptide (BNP) and C-reactive protein (CRP). To establish the normality pattern of these markers studied, a control group, with healthy individuals, will be performed.An anthropometric evaluation will be performed with measurements of weigh, height, arm circumference, triceps skin fold. According to nutritional status, it will be calculated the caloric and protein needs of each patient and, to monitor the consumption, in each consult will be applied the 24-hour food recall and calculated the consumption from it. In order to measure the appetite of the patients, in each consult, an appetite questionnaire will be applied. To statistical analysis, the test of Kolmogorov-Smirnov will be used to assess whether the distribution is normal for the quantitative variables. If the variable follows normal distribution, it will be described as mean and standard deviation, otherwise, it will be described as median and interquartile range. The groups will be compared using t-Student or Mann-Whitney tests. The categorical variables will be presented descriptively with absolute and relative frequencies. The association between categorical variables will be analyzed with chi square test or Fisher exact test or likelihood ratio test. For the repeated measures, will be used the ANOVA test or Friedman test and Wilcoxon signs. The analyzes will be performed according to the intent-to-treat principle and the two-tailed tests. The value of p<0,5 will be considered statistically significant.
- Conditions
- Heart Failure
- Being tested
- Probiotic, Placebo
- Keywords
- Probiotics, Inflammation, Heart failure, Intestinal microbiota
- 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.
ProbioticDietary supplement
Those patients in group Probiotic will receive the capsules containing Lactobacillus acidophilus and will need to take one of it everyday during the study.
PlaceboOther
Those patients in group Placebo will receive the capsules containing vegetable oil and corn starch and will need to take one of it everyday during the study.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | These patients will receive capsules containing vegetable oil and corn starch Receives: Other: Placebo |
| Probiotic | Active comparator | These patients will receive capsules containing Lactobacillus acidophilus Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of probiotics in serum levels of TNF-alpha
Probiotics should improve serum levels of tumor necrosis alpha (TNF-alpha)
Measured: six months
Secondary outcomes (7)
Effects of probiotics in serum levels of lipopolysaccharide LPS (ng/mL)
Probiotics should improve serum levels of LPS (ng/mL)
Measured: six months
Effects of probiotics in serum levels of interleukin 1 (IL 1) (pg/mL)
Probiotics should improve serum levels of IL 1 (pg/mL)
Measured: six months
Effects of probiotics in serum level of interleukin 6 (IL 6) (pg/mL)
Probiotics should improve serum levels of IL 6 (pg/mL)
Measured: six months
Effects of probiotics in serum levels of interleukin 10 (IL 10)(pg/mL)
Probiotics should improve serum levels of IL 10 (pg/mL)
Measured: six months
Effects of probiotics in serum levels of B-type natriuretic peptide (BNP) (pg/mL)
Probiotics should improve serum levels of BNP (pg/mL)
Measured: six months
Effects of probiotics in serum levels of C-reactive protein (CRP) (mg/L)
Probiotics should improve serum levels of CRP (mg/L)
Measured: six months
Effects of probiotics in appetite
Probiotics should improve the appetite
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start6 Nov 2018
- Primary completion1 Dec 2019 (estimated)
- Study completion31 Aug 2020 (estimated)
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.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Fernando Bacal, University of Sao Paulo General Hospital
- Investigators
- Fernando Bacal, MD PhD, Principal investigator, Heart Institute (InCor), University of Sao Paulo, Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968549
- Sponsor's protocol ID
- PROBHF
- Acronym
- PROBHF
- Status last verified
- May 2019
- First submitted
- 1 Nov 2018
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Importance of Intestinal Microbiota in Patients With Heart Failure - Randomized, Double-blind Study
- ClinicalTrials.gov ID
- NCT03968549
- Acronym / sponsor ID
- PROBHF / PROBHF
- Conditions
- Heart Failure
- Keywords
- Probiotics, Inflammation, Heart failure, Intestinal microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 30 May 2019 (actual)
- 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.
Cachexia is a very common condition in patients with advanced heart failure (HF) and is considered a predictor of mortality. Studies have been carried out in an attempt to discover the mechanisms that leads to cachexia in order to improve the therapies and the survival of these patients. Some of these studies give the hypothesis that the gastrointestinal tract, more precisely the intestine, can collaborate with cachexia. Some of these studies suggest that, the intestinal mucosa, due to hypoperfusion, becomes more permeable to some substances, as like endotoxins, being the lipopolysaccharide (LPS) one of them. The circulating LPS can stimulate the increase of tumor necrosis alpha (TNF-alpha) further increasing the inflammation and, consequently, contributing to the worsening of prognosis. The intestinal microbiota is also affected by hypoperfusion, contributing with increase of permeability. As known, probiotics can help to maintain or recover the microbiota and maintain a healthy intestinal barrier. In view of the importance of microbiota to inflammation in the prognosis of the patients and the performance of microbiota in maintenance of intestinal barrier, this study has as primary objective to verify the influence of supplementation of the probiotic Lactobacillus acidophilus (LA) in the lowering of serum levels of TNF-alpha in the patients with HF.
Detailed description
The present study will be a clinical trial compounded by two parallel arms, randomized, double-blind (researcher-patient), placebo-controlled, with patients with heart failure (HF), functional class according the New York Heart Association (NYHA) III and IV. It will be included 58 patients, 29 will receive probiotics and 29 will receive placebo. These patients will be accompanied during 6 months and should take one capsule every day during the study. In the beginning of the study and at the end, venous blood sample will be collected of each patient for laboratory measurement of TNF alpha, interleukins 1,6 and 10, LPS, B-type natriuretic peptide (BNP) and C-reactive protein (CRP). To establish the normality pattern of these markers studied, a control group, with healthy individuals, will be performed.An anthropometric evaluation will be performed with measurements of weigh, height, arm circumference, triceps skin fold. According to nutritional status, it will be calculated the caloric and protein needs of each patient and, to monitor the consumption, in each consult will be applied the 24-hour food recall and calculated the consumption from it. In order to measure the appetite of the patients, in each consult, an appetite questionnaire will be applied. To statistical analysis, the test of Kolmogorov-Smirnov will be used to assess whether the distribution is normal for the quantitative variables. If the variable follows normal distribution, it will be described as mean and standard deviation, otherwise, it will be described as median and interquartile range. The groups will be compared using t-Student or Mann-Whitney tests. The categorical variables will be presented descriptively with absolute and relative frequencies. The association between categorical variables will be analyzed with chi square test or Fisher exact test or likelihood ratio test. For the repeated measures, will be used the ANOVA test or Friedman test and Wilcoxon signs. The analyzes will be performed according to the intent-to-treat principle and the two-tailed tests. The value of p<0,5 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboThese patients will receive capsules containing vegetable oil and corn starch |
| Probiotic | Active comparator | Dietary Supplement: ProbioticThese patients will receive capsules containing Lactobacillus acidophilus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with heart failure NYHA functional class III and IV;
- Medications optimized for at least 2 months;
- No hospitalizations for HF decompensated or acute myocardial infarction in the last 30 days;
- Have signed the Free and Informed Consent Form
Key exclusion criteria (5 listed)
- Do not accept to participate in the study or do not signed the Free and Informed Consent Form
- Have used antibiotics and/or corticosteroids in the last 30 days;
- Clinical conditions that can affect the inflammatory profile such as inflammatory bowel disease, arthrosis, among others;
- Be pregnant;
- Have been submitted to a cardiac surgery in the last 6 months or other surgery in the last 3 months
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 |
|---|---|---|
| ProbioticThose patients in group Probiotic will receive the capsules containing Lactobacillus acidophilus and will need to take one of it everyday during the study. | Dietary supplement | Probiotic |
| PlaceboThose patients in group Placebo will receive the capsules containing vegetable oil and corn starch and will need to take one of it everyday during the study. | Other | Placebo |
Primary outcome
Effects of probiotics in serum levels of TNF-alpha
Time frame: six months
Probiotics should improve serum levels of tumor necrosis alpha (TNF-alpha)
7 secondary outcomes
Effects of probiotics in serum levels of lipopolysaccharide LPS (ng/mL)
Time frame: six months
Effects of probiotics in serum levels of interleukin 1 (IL 1) (pg/mL)
Time frame: six months
Effects of probiotics in serum level of interleukin 6 (IL 6) (pg/mL)
Time frame: six months
Effects of probiotics in serum levels of interleukin 10 (IL 10)(pg/mL)
Time frame: six months
Effects of probiotics in serum levels of B-type natriuretic peptide (BNP) (pg/mL)
Time frame: six months
Effects of probiotics in serum levels of C-reactive protein (CRP) (mg/L)
Time frame: six months
Effects of probiotics in appetite
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Fernando Bacal, MD PhD principal investigator
Heart Institute (InCor), University of Sao Paulo, Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Heart Failure, run by University of Sao Paulo General Hospital 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 May 2019. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Bacal, MD PhD ((11) 2661-5482, fbacal@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of probiotics in serum levels of TNF-alpha (time frame: six 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 30 May 2019.