Probiotics and smectite absorbent gel formulation reduce liver stiffness, transaminase and cytokine levels in NAFLD associated with type 2 diabetes: a randomized clinical study

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 inflam­mation.