Probiotics and Inflammatory Status in Patients With Heart Failure

NCT03968549 | Unknown DMC

• 1 other identifier: PROBHF
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Probiotics; Inflammation; Heart failure; Intestinal microbiota

Outcome Measures

Primary Outcomes (1)

• Effects of probiotics in serum levels of TNF-alpha

  Probiotics should improve serum levels of tumor necrosis alpha (TNF-alpha)

  six months

Secondary Outcomes (7)

• Effects of probiotics in serum levels of lipopolysaccharide LPS (ng/mL)

  six months

• Effects of probiotics in serum levels of interleukin 1 (IL 1) (pg/mL)

  six months

• Effects of probiotics in serum level of interleukin 6 (IL 6) (pg/mL)

  six months

• Effects of probiotics in serum levels of interleukin 10 (IL 10)(pg/mL)

  six months

• Effects of probiotics in serum levels of B-type natriuretic peptide (BNP) (pg/mL)

  six months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

These patients will receive capsules containing vegetable oil and corn starch

Other: Placebo

Probiotic

ACTIVE COMPARATOR

These patients will receive capsules containing Lactobacillus acidophilus

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_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.

Probiotic

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Fernando Bacal

São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Heart Failure; Inflammation

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Fernando Bacal, MD PhD

  Heart Institute (InCor), University of Sao Paulo, Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Bacal, MD PhD

CONTACT

(11) 2661-5482; fbacal@uol.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Heart Transplant Unit

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: May 30, 2019
• Study Start: November 6, 2018
• Primary Completion: December 1, 2019
• Study Completion: August 31, 2020
• Last Updated: May 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)