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Probiotics and Inflammatory Status in Patients With Heart Failure

NCT03968549 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2019-05-30

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Fernando Bacal, MD PhD · Heart Institute (InCor), University of Sao Paulo, Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-06
Primary Completion
2019-12-01
Completion
2020-08-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03968549 on ClinicalTrials.gov