Probiotics and Inflammatory Status in Patients With Heart Failure
Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · May 29, 2019
Trial Information
Current as of June 06, 2025
Unknown status
Keywords
ClinConnect Summary
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, i...
Gender
ALL
Eligibility 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
About University Of Sao Paulo General Hospital
The University of São Paulo General Hospital (Hospital das Clínicas da Universidade de São Paulo) is a leading clinical research institution in Brazil, renowned for its commitment to advancing medical knowledge and patient care. As an academic hospital affiliated with one of the largest and most prestigious universities in Latin America, it integrates clinical practice, education, and research. The hospital conducts a wide array of clinical trials across various medical disciplines, aiming to develop innovative therapies and improve healthcare outcomes. With a multidisciplinary team of healthcare professionals and access to cutting-edge facilities, the University of São Paulo General Hospital is dedicated to fostering scientific advancements and addressing critical health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
São Paulo, , Brazil
Patients applied
Trial Officials
Fernando Bacal, MD PhD
Principal Investigator
Heart Institute (InCor), University of Sao Paulo, Medical School
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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