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Probiotics and Inflammatory Status in Patients With Heart Failure (PROBHF)

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ClinicalTrials.gov Identifier: NCT03968549
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Fernando Bacal, University of Sao Paulo General Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Heart Failure Dietary Supplement: Probiotic Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Importance of Intestinal Microbiota in Patients With Heart Failure - Randomized, Double-blind Study
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Placebo Comparator: Placebo
These patients will receive capsules containing vegetable oil and corn starch
Other: Placebo
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.

Active Comparator: Probiotic
These patients will receive capsules containing Lactobacillus acidophilus
Dietary Supplement: Probiotic
Those patients in group Probiotic will receive the capsules containing Lactobacillus acidophilus and will need to take one of it everyday during the study.




Primary Outcome Measures :
  1. Effects of probiotics in serum levels of TNF-alpha [ Time Frame: six months ]
    Probiotics should improve serum levels of tumor necrosis alpha (TNF-alpha)


Secondary Outcome Measures :
  1. Effects of probiotics in serum levels of lipopolysaccharide LPS (ng/mL) [ Time Frame: six months ]
    Probiotics should improve serum levels of LPS (ng/mL)

  2. Effects of probiotics in serum levels of interleukin 1 (IL 1) (pg/mL) [ Time Frame: six months ]
    Probiotics should improve serum levels of IL 1 (pg/mL)

  3. Effects of probiotics in serum level of interleukin 6 (IL 6) (pg/mL) [ Time Frame: six months ]
    Probiotics should improve serum levels of IL 6 (pg/mL)

  4. Effects of probiotics in serum levels of interleukin 10 (IL 10)(pg/mL) [ Time Frame: six months ]
    Probiotics should improve serum levels of IL 10 (pg/mL)

  5. Effects of probiotics in serum levels of B-type natriuretic peptide (BNP) (pg/mL) [ Time Frame: six months ]
    Probiotics should improve serum levels of BNP (pg/mL)

  6. Effects of probiotics in serum levels of C-reactive protein (CRP) (mg/L) [ Time Frame: six months ]
    Probiotics should improve serum levels of CRP (mg/L)

  7. Effects of probiotics in appetite [ Time Frame: six months ]
    Probiotics should improve the appetite



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968549


Contacts
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Contact: Fernando Bacal, MD PhD (11) 2661-5482 fbacal@uol.com.br

Locations
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Brazil
Fernando Bacal Recruiting
São Paulo, Brazil
Contact: Fernando Bacal    (11) 2661-5482    fbacal@uol.com.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Fernando Bacal, MD PhD Heart Institute (InCor), University of Sao Paulo, Medical School

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Responsible Party: Fernando Bacal, Director of Heart Transplant Unit, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03968549     History of Changes
Other Study ID Numbers: PROBHF
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Fernando Bacal, University of Sao Paulo General Hospital:
Probiotics
Inflammation
Heart failure
Intestinal microbiota
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases