Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Adults NAFLD Patients (DELI_NAFLD Study)
Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, Hepatic Steatosis
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring Postbiotics, metabiotics, L. rhamnosus, L. delbrueckii, Obesity, Non-Alcoholic Fatty Liver Disease
Eligibility Criteria
Inclusion Criteria: adult participants (ages 18-70) presence of NAFLD diagnosed according to the recommendations of the American Gastroenterology Association (AGA) and American Association for the Study of Liver Disease (AASLD); 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 NAFLD MRI-PDFF of at least 6.4%; 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. Exclusion Criteria: recent hepatitis, or positive screening test for hepatitis B (hepatitis B virus surface antigen) or hepatitis C (hepatitis C antibody); alcohol abuse (>20 g/day (2 standard drinks) in women or > 30 g/d (3 drinks) in men over a two-year period); 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; regular use of an agents with gut microbiota modulation activity (antibiotic, pro-, pre-, post or synbiotics supplement etc.) within 3 months prior to enrollment; allergy on probiotics or their components; 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; uncontrolled cardiovascular or respiratory disease, decompensated liver disease including ascites, encephalopathy or variceal bleeding, active malignancy, or chronic infections; 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; participation in other clinical trials; presence of pregnancy or lactation.
Sites / Locations
- Bogomolets National Medical UniversityRecruiting
- Kyiv City Clinical Endocrinology CenterRecruiting
- Center for Innovative Medical Technologies of the National Academy of Sciences of UkraineRecruiting
- Danylo Halytsky Lviv National Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Probiotic lysate (postbiotic and metabiotc) group
Placebo group
oral, 2 capsules per day (BID) for 3 month treatment
placebo, oral, 2 capsules per day (BID) for 3 month treatment