NCT05804422Completed
Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Adults NAFLD Patients (DELI_NAFLD Study)
Efficacy and Safety of Probiotic Lysate (Postbiotic and Metabiotic) Supplementation in Adults NAFLD Patients
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics on hepatic fat content as measured by MRI-PDFF and ultrasonography, liver stiffness (LS) measured by Shear Wave Elastography (SWE) and anthropomorphic variables in NAFLD patients. The study will include 3 periods. Screening period of up to 1 weeks to assess the eligibility to inclusion/exclusion criteria. Treatment period for 3 month where the participants will receive a twice daily oral dose of postbiotics (cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023) at the assigned dose of 100mg or placebo in capsules. During this period monthly phone contacts will be done for assessment of compliance and safety concerns. Follow-up period of up to 3 month.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 16 Mar 2023
- Start date
- 1 May 2023
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Bogomolets National Medical University
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05804422
What you commit to
- Study type: Interventional
- Participants enrolled: 39
- From 1 May 2023 to the primary completion date, 31 Dec 2023
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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;
Other
- 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.
Who the study is looking for
- 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%;
- BMI 25-39.9 kg/m2;
- aspartate transaminase (AST) and alanine transaminase (ALT) ≤3x upper limit of normal;
- written informed consent.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Kyiv City Clinical Endocrinology Center Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Bogomolets National Medical University Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Danylo Halytsky Lviv National Medical University Coordinator of this site? Confirm its status | Lviv | Ukraine | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.