An interventional study of Probiotic lysate (postbiotic and metabiotc) and Placebo in Metabolic Dysfunction Associated Steatotic Liver Disease, Steatotic Liver Disease and Hepatic Steatosis, sponsored by Bogomolets National Medical University. Completed at 5 sites in Ukraine. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Bogomolets National Medical University · Not applicable, Interventional, and Treatment
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 biochemichal hepatic steatosis indeces, serum lipid profile, transaminases activity and chronic systemic inflammatory markers in MASLD 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.
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 biochemichal hepatic steatosis indeces, serum lipid profile, transaminases activity and chronic systemic inflammatory markers in MASLD 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.
Exclusion Criteria:
oral, 2 capsules per day (BID) for 3 month treatment
Dietary Supplement: Probiotic lysate (postbiotic and metabiotc)
placebo, oral, 2 capsules per day (BID) for 3 month treatment
Dietary Supplement: Placebo
Each capsule contains 100 mg of cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023 in powder
Placebo
changes in fatty liver index (FLI)
FLI = \[e 0.953\*loge (triglycerides) + 0.139\*BMI + 0.718\*loge (ggt) + 0.053\*waist circumference - 15.745) / (1 + e 0.953\*loge (triglycerides) + 0.139\*BMI + 0.718\*loge (ggt) + 0.053\*waist circumference - 15.745)\] × 100
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline]
hepatic steatosis index (HSI)
HSI = 8 x ALT/AST + BMI(+ 2 if type 2 diabetes yes, + 2 if female)
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline]
TyG index
TyG = ln \[Fasting triglyceride (mg / dl) x Fasting glucose (mg / dl)\] / 2
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline]
Concentration of AST
AST in IU/L
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline]
Concentration of ALT
ALT in IU/L
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline]
Concentration of Gamma-glutamyl Transferase (GGT)
GGT in IU/L
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline]
Concentration of Total Cholesterol (TC)
TC in mmol/l
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline]
Concentration of Tryglicerides (TG)
TG in mmol/l
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline]
Concentration of high sensitivity CRP (hs-CRP)
hs-CRP in mg/L
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline]
waist circumferences (WC)
WC in cm
Time frame: 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
Time frame: 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
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline]
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Bogomolets National Medical University