Synbiotic supplementation in lean patients with non-alcoholic fatty liver disease: A pilot, randomised, double-blind, placebo-controlled, clinical trial

Although non-alcoholic fatty liver disease (NAFLD) is the leading aetiology of liver disorders in the world, there is no proven treatment for NAFLD patients with normal or low BMI. The aim of this study was to evaluate the efficacy of synbiotics supplementation in NAFLD patients with normal or low BMI. In this randomised, double-blind, placebo-controlled, clinical trial, fifty patients with NAFLD were assigned to take either a synbiotic supplement or a placebo capsule for 28 weeks. Both groups were advised to follow a healthy lifestyle. At the end of the study, hepatic steatosis and fibrosis reduced in both groups; however, the mean reduction was significantly greater in the synbiotic group rather than in the placebo group (P<0·001). Furthermore, serum levels of fasting blood sugar, TAG and most of the inflammatory mediators reduced in the synbiotic group significantly compared with the placebo group (P<0·05). Our results provide evidence that synbiotic supplementation improves the main features of NAFLD in patients with normal and low BMI, at least partially through reduction in inflammatory indices. Further studies are needed to address the exact mechanism of action of these effects

Methods

The details of the study protocol have been explained previously. In brief, patients were identified and recruited from a referral centre for FibroScan examination (Echosense). The diagnosis of NAFLD was established according to the presence of steatosis with controlled attenuation parameter (CAP) score of >263, associated with elevated alanine aminotransferase (ALT) >60 U/l for 6 months before the study and at the time of randomisation. Patients with NAFLD who were 18 years or older, with BMI≤25, lack of history of alcohol consumption and no evidence of any other acute and chronic disorders of the liver (hepatitis B, C, etc.), biliary disease, autoimmune diseases, cancer and inherited disorders affecting the liver were included. Participants who took antibiotics, probiotic supplements and/or hepatotoxic medicines within 6 months before the start of the study and during the study, pregnant and breast-feeding women and those with >10 % of body weight loss during the study period were excluded from the study