The main treatments for patients with nonalcoholic fatty liver disease (NAFLD) are currently based on lifestyle changes, including ponderal decrease and dietary management. However, a subgroup of patients with nonalcoholic steatohepatitis (NASH), who are unable to modify their lifestyle successfully, may benefit from pharmaceutical support. Several drugs targeting pathogenic mechanisms of NAFLD have been evaluated in clinical trials for the treatment of NASH. Farnesoid X receptor (FXR) is a nuclear key regulator controlling several processes of the hepatic metabolism. NAFLD has been proven to be associated with abnormal FXR activity. Obeticholic acid (OCA) is a first-in-class selective FXR agonist with anticholestatic and hepato-protective properties. Currently, OCA is registered for the treatment of primary biliary cholangitis. However, promising effects of OCA on NASH and its metabolic features have been reported in several studies.

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Introduction. In double-blind single center randomized clinical trial (RCT), the efficacy of alive probiotics supplementation with smectite gel vs. placebo in type 2 diabetes patient with non-alcoholic fatty liver disease (NAFLD) detected on ultrasonography (US) were studied. Material and methods. A total of 50 patients met the criteria for inclusion. They were randomly assigned to receive Symbiter Forte combination of probiotic biomass with smectite gel (250 mg) or placebo for 8-weeks. The primary main outcomes were the change in fatty liver index (FLI) and liver stiffness (LS) measured by shear wave elastography (SWE). Secondary outcomes were the changes in transaminases activity, serum lipids and cytokines levels. Results. All subjects completed the study and received more than 90% of prescribed sachets. In respect to our primary endpoints, FLI and LS insignificant decrease in both interventional and placebo groups. However, when we compare mean changes across groups from baseline, expressed in absolute values, the reduction of both LS (-0.254 ± 0.85 vs. 0.262 ± ± 0.77; p = 0.031) were observed. Analysis of secondary outcomes showed that co-administration of probiotic with smectite lead to significant reduction of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total cholesterol, IL-1b, and tumor necrosis factor (TNF-a) after 8 weeks. Conclusion. In this RCT, we confirmed previously reported animal data, showing that co-administration of probiotic with smectite manifested with reduction of LS, liver transaminases and chronic systemic inflam