Could a probiotic supplement help reverse fatty liver?
NCT ID NCT05804422
First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time
Summary
This study tests whether a daily probiotic lysate supplement can reduce fat and stiffness in the liver of adults with non-alcoholic fatty liver disease (NAFLD). Participants take either the supplement or a placebo for three months, and doctors measure changes using MRI and ultrasound. The goal is to see if this simple, over-the-counter-style approach can improve liver health without major side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Probiotic lysate (postbiotic and metabiotic) from L. rhamnosus DV
- What this could lead to
- If effective, this supplement could offer a simple, safe way to reduce liver fat and improve liver health in people with NAFLD.
- What could go wrong
- This is a small, short-term study with only 39 participants. Results may not apply to everyone, and the supplement may not outperform placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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39 people
The number who actually took part.
- Started
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May 2023
- Finished
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Dec 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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%; * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bogomolets National Medical University
Kyiv, 01601, Ukraine
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Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine
Kyiv, 02000, Ukraine
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Danylo Halytsky Lviv National Medical University
Lviv, 79010, Ukraine
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Kyiv City Clinical Endocrinology Center
Kyiv, 01601, Ukraine
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Other studies related to the condition(s) this trial covers.
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