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Could a probiotic supplement help reverse fatty liver?

NCT ID NCT06352697

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study tests whether a daily capsule containing fragments of a probiotic bacterium (L. rhamnosus) can reduce liver fat and improve blood markers in adults with metabolic dysfunction-associated steatotic liver disease (MASLD). Participants take either the supplement or a placebo for three months, with follow-up for another three months. The goal is to see if this postbiotic approach safely lowers liver fat and inflammation.

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
What this could lead to
If effective, this supplement could offer a simple, non-drug way to reduce liver fat and inflammation in people with fatty liver disease.
What could go wrong
This is a small, early-stage trial with only 50 participants, so results may not apply broadly. The supplement may not significantly improve liver health, and long-term effects are unknown.

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

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

50 people

The number who actually took part.

Started

May 2024

Finished

Jan 2025

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

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

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 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. 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

  • Bogomolets National Medical University

    Kyiv, 01601, Ukraine

  • Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine

    Kyiv, 02000, Ukraine

  • Danylo Halytsky Lviv National Medical University

    Lviv, 79010, Ukraine

  • Kyiv City Clinical Endocrinology Center

    Kyiv, 01601, Ukraine

  • Taras Shevchenko National University of Kyiv

    Kyiv, 01601, Ukraine

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