Non-Alcoholic Fatty Liver DiseaseNCT05804422
Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Adults NAFLD Patients (DELI_NAFLD Study)
A study testing Probiotic lysate (postbiotic and metabiotc) in people with Non-Alcoholic Fatty Liver Disease and Non Alcoholic Fatty Liver, run by Bogomolets National Medical University at 4 sites in Ukraine.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, Hepatic Steatosis
- What is being tested?
- Probiotic lysate (postbiotic and metabiotc)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 4 sitesUkraine
- Study dates
- 1 May 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Ukraine4 sites
Bogomolets National Medical University
Kyiv, 01601
Kyiv City Clinical Endocrinology Center
Kyiv, 01601
Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine
Kyiv, 02000
Danylo Halytsky Lviv National Medical University
Lviv, 79010
About this study
Official title: Efficacy and Safety of Probiotic Lysate (Postbiotic and Metabiotic) Supplementation in Adults NAFLD Patients
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.
Read the detailed description
The scientific literature points to the beneficial properties of probiotics in the process of regulating metabolism, yet at the same time, some scientific papers question the effectiveness and the safety of probiotics. In turn, postbiotics and metabiotics are preparations of inanimate microorganisms and / or their components, which are directly identified with the safety of their use and the health benefits of the host. Due to the chemical structure of postbiotics and metabiotics, it is found that they have many health benefits; in particular, they have a local effect on certain tissues of the intestinal epithelium, and influence on many other organs and tissues. It is postbiotics metabolites and metabiotics structural cell fragments that create the appearance of a therapeutic effect of probiotics, which, in turn, limits the risk of introducing living microorganisms into a weakened immune defence. It should also be pointed out that postbiotics and metabiotics are more stable and have a longer shelf-life.
The practical use of probiotics and the study of the mechanism of their action made lately to find that a certain level of biological activity is preserved by dead probiotic cells and even their lysates, which are the natural mixes of metabiotic and postbiotic substances; a biological activity which is strongly oriented toward gut health and immune system regulation. Because probiotic lysates demonstrated biological activity without any of the potential adverse side effects associated with live bacterial cells, one of the future goal is research of the novel postbiotics and metabiotics substances, their individual structures and biological characteristics for understanding their way of communications with host cells and microbiota representatives.
Considering the high biological activity and safety of postbiotics and metabiotic substances, it can be concluded that such a treatment vector will be promising in the near future. That's why our investigation will concentrate on postbiotic, a supplement containing dry fermented cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023.
Recent scientific animal studies on the stated issues point to the benefits of some postbiotics in treating metabolic disorders. 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. All capsules will be identical with similar organoleptic characteristics (e.g., taste and appearance).. Follow-up period of up to 3 month.
The pre-randomization period will be designed to minimize the effects of dietary changes on metabolic markers. For this purpose, 2 weeks before the study start, after inform consent signed, patients were instructed in one-on-one sessions with a dietitian to follow a therapeutic lifestyle-change diet as classified by the NCEP. In addition, participants were instructed to continue with stable anti-hyperglycemic treatment and received standardized mild physical training for 1 hour per day.
Patients who underwent the study were instructed to take the trial medication as prescribed. Throughout the study, weekly phone follow-up visits were provided for assessment of compliance, adherence to the protocol, as well as the recording of adverse events. The effectiveness of therapy was compared and evaluated separately in the two groups.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, Hepatic Steatosis, Fatty Liver
- Being tested
- Probiotic lysate (postbiotic and metabiotc), Placebo
- Keywords
- Postbiotics, metabiotics, L. rhamnosus, L. delbrueckii, Obesity, Non-Alcoholic Fatty Liver Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic lysate (postbiotic and metabiotc)Dietary supplement
Also called Del-Immune V® Extra
Each capsule contains 100 mg of cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023 in powder
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic lysate (postbiotic and metabiotc) group | Active comparator | oral, 2 capsules per day (BID) for 3 month treatment Receives: Dietary Supplement: Probiotic lysate (postbiotic and metabiotc) |
| Placebo group | Placebo comparator | placebo, oral, 2 capsules per day (BID) for 3 month treatment Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in hepatic fat content
will be measured by magnetic resonance proton density fat fraction (MRI-PDFF) in %
Measured: at 3 month (end of treatment)
changes in hepatic fat content
will be measured by ultrasound attenuation coefficient measurement (ACM) in dB/cm
Measured: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
Secondary outcomes (6)
liver stiffness (LS)
liver stiffness (LS) will be measured by Shear Wave Elastography (SWE) and expressed in kPa
Measured: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
hs-CRP
hs-CRP in mg/L
Measured: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
waist circumferences (WC)
WC in cm
Measured: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
body mass index (BMI)
weight in kg and height in meters will be combined to report BMI in kg/m^2
Measured: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
body fat in percentage
fat content (%) using electronic scales-analyzers of body composition Tanita Scale BC-601
Measured: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
visceral fat content
visceral fat content using electronic scales-analyzers of body composition Tanita Scale BC-601
Measured: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 May 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bogomolets National Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Taras Shevchenko National University of Kyiv, Danylo Halytsky Lviv National Medical University, Kyiv City Clinical Endocrinology Center, Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine, MirImmunoFarm, Stellar Biotics
- Responsible party
- Principal investigator, Nazarii Kobyliak, Bogomolets National Medical University
- Investigators
- Nazarii Kobyliak, PhD, Principal investigator, Bogomolets National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804422
- Sponsor's protocol ID
- DELI_NAFLD
- Status last verified
- Jun 2026
- First submitted
- 16 Mar 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Probiotic Lysate (Postbiotic and Metabiotic) Supplementation in Adults NAFLD Patients
- ClinicalTrials.gov ID
- NCT05804422
- Acronym / sponsor ID
- DELI_NAFLD
- Conditions
- Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, Hepatic Steatosis, Fatty Liver
- Keywords
- Postbiotics, metabiotics, L. rhamnosus, L. delbrueckii, Obesity, Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Bogomolets National Medical UniversityUniversity, hospital or other
- Collaborators
- Taras Shevchenko National University of Kyiv, Danylo Halytsky Lviv National Medical University, Kyiv City Clinical Endocrinology Center, Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine, MirImmunoFarm, Stellar Biotics
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The scientific literature points to the beneficial properties of probiotics in the process of regulating metabolism, yet at the same time, some scientific papers question the effectiveness and the safety of probiotics. In turn, postbiotics and metabiotics are preparations of inanimate microorganisms and / or their components, which are directly identified with the safety of their use and the health benefits of the host. Due to the chemical structure of postbiotics and metabiotics, it is found that they have many health benefits; in particular, they have a local effect on certain tissues of the intestinal epithelium, and influence on many other organs and tissues. It is postbiotics metabolites and metabiotics structural cell fragments that create the appearance of a therapeutic effect of probiotics, which, in turn, limits the risk of introducing living microorganisms into a weakened immune defence. It should also be pointed out that postbiotics and metabiotics are more stable and have a longer shelf-life.
The practical use of probiotics and the study of the mechanism of their action made lately to find that a certain level of biological activity is preserved by dead probiotic cells and even their lysates, which are the natural mixes of metabiotic and postbiotic substances; a biological activity which is strongly oriented toward gut health and immune system regulation. Because probiotic lysates demonstrated biological activity without any of the potential adverse side effects associated with live bacterial cells, one of the future goal is research of the novel postbiotics and metabiotics substances, their individual structures and biological characteristics for understanding their way of communications with host cells and microbiota representatives.
Considering the high biological activity and safety of postbiotics and metabiotic substances, it can be concluded that such a treatment vector will be promising in the near future. That's why our investigation will concentrate on postbiotic, a supplement containing dry fermented cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023.
Recent scientific animal studies on the stated issues point to the benefits of some postbiotics in treating metabolic disorders. 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. All capsules will be identical with similar organoleptic characteristics (e.g., taste and appearance).. Follow-up period of up to 3 month.
The pre-randomization period will be designed to minimize the effects of dietary changes on metabolic markers. For this purpose, 2 weeks before the study start, after inform consent signed, patients were instructed in one-on-one sessions with a dietitian to follow a therapeutic lifestyle-change diet as classified by the NCEP. In addition, participants were instructed to continue with stable anti-hyperglycemic treatment and received standardized mild physical training for 1 hour per day.
Patients who underwent the study were instructed to take the trial medication as prescribed. Throughout the study, weekly phone follow-up visits were provided for assessment of compliance, adherence to the protocol, as well as the recording of adverse events. The effectiveness of therapy was compared and evaluated separately in the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic lysate (postbiotic and metabiotc) group | Active comparator | Dietary Supplement: Probiotic lysate (postbiotic and metabiotc)oral, 2 capsules per day (BID) for 3 month treatment |
| Placebo group | Placebo comparator | Dietary Supplement: Placeboplacebo, oral, 2 capsules per day (BID) for 3 month treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic lysate (postbiotic and metabiotc)Also: Del-Immune V® ExtraEach capsule contains 100 mg of cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023 in powder | Dietary supplement | Probiotic lysate (postbiotic and metabiotc) group |
| PlaceboPlacebo | Dietary supplement | Placebo group |
Primary outcome
changes in hepatic fat content
Time frame: at 3 month (end of treatment)
will be measured by magnetic resonance proton density fat fraction (MRI-PDFF) in %
changes in hepatic fat content
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
will be measured by ultrasound attenuation coefficient measurement (ACM) in dB/cm
6 secondary outcomes
liver stiffness (LS)
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
hs-CRP
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
waist circumferences (WC)
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
body mass index (BMI)
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
body fat in percentage
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
visceral fat content
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazarii Kobyliak, PhD principal investigator
Bogomolets National Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic lysate (postbiotic and metabiotc) in people with Non-Alcoholic Fatty Liver Disease and Non Alcoholic Fatty Liver, run by Bogomolets National Medical University at 4 sites in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in hepatic fat content (time frame: at 3 month (end of treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.