Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Adults MASLD Patients (DELI_MASLD Study)

Korábbi kezelés

• regular use of an agents with gut microbiota modulation activity (antibiotic, pro-, pre-, post or synbiotics supplement etc.) within 3 months prior to enrollment;
• use of agents such as vitamin E, omega-3 fatty acids or medications with evidence for effects on NAFLD (pioglitazone, GLP-1 analogues, dipeptidyl peptidase IV inhibitors, ursodeoxycholic acid);
• subjects with a history of bariatric surgery or significant weight loss (\> 5% body weight) or rapid weight loss (\> 1.6kg/week), within 6 months prior to enrollment;
• participant who had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated), and/or had a confirmed case of COVID-19 within 4 weeks prior to enrollment;

Más betegség

• recent hepatitis, or positive screening test for hepatitis B (hepatitis B virus surface antigen) or hepatitis C (hepatitis C antibody);
• drug-induced liver disease, Wilson\'s disease, hereditary deficiency of antitrypsin-1 and idiopathic hemochromatosis;
• history of decompensated liver disease including ascites, encephalopathy or variceal bleeding;
• allergy on probiotics or their components;
• uncontrolled cardiovascular or respiratory disease, decompensated liver disease including ascites, encephalopathy or variceal bleeding, active malignancy, or chronic infections;

Egyéb

• alcohol abuse (\>20 g/day (2 standard drinks) in women or \> 30 g/d (3 drinks) in men over a two-year period);
• participation in other clinical trials;
• presence of pregnancy or lactation.

• adult participants (ages 18-70)
• presence of MASLD according to \"A multisociety Delphi consensus statement", 2023;
• the diagnosis of fatty liver was based on the results of abdominal ultrasonography. Of 4 known criteria (hepato-renal echo contrast, liver brightness, deep attenuation, and vascular blurring), the participants were required to have hepato-renal contrast and liver brightness to be given a diagnosis of SLD
• fatty liver index (FLI) more than 60;
• BMI 25-39.9 kg/m2;
• aspartate transaminase (AST) and alanine transaminase (ALT) ≤3x upper limit of normal;
• written informed consent.