The effects of Bacillus coagulans supplementation in patients with non-alcoholic fatty liver disease: A randomized, placebo-controlled, clinical trial

Background: The aim of this study was to evaluate the effects of supplementation with 109 spores of Bacillus coagulans (GBI-30) plus inulin in patients with non-alcoholic fatty liver disease (NAFLD). Methods: In a randomized, double-blind, placebo-controlled clinical trial, fifty three patients with NAFLD were randomly assigned to receive either a synbiotic or a placebo capsule for 12 weeks. The primary outcome was reduction in steatosis score in Fibroscan exam. Results: At the end of study, serum alanine aminotransferase and g glutamine transaminase decreased significantly more in synbiotic group compared to placebo group (p = 0.001, and p = 0.004, respectively). Synbiotic supplementation significantly reduced serum tumor necrosis factor -a (p = 0.03) and nuclear factor-kB activity (p = 0.04). Moreover, hepatic steatosis reduced significantly more in synbiotic group compared to placebo group (p < 0.001). Conclusion: Our results indicate that 12 weeks supplementation with B. coagulans plus inulin is beneficial for treatment of NAFLD and its related inflammation without any significant effects on related cardiovascular risk factors.