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

Abstract

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-α) 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.