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.

Effects of Synbiotics Supplementation in Lean Patients with Nonalcoholic Fatty Liver Disease: Study Protocol of a Pilot Randomized Double-blind Clinical Trial.

INTRODUCTION: Currently, Nonalcoholic Fatty Liver Disease (NAFLD) is the most common liver disease in the world. The only approved treatment for it is lifestyle modification and weight loss; however, there is no treatment option for patients with normal or low body mass index (BMI). The aim of this study is to evaluate the efficacy of synbiotics supplementation in NAFLD patients with normal or low BMI. METHODS AND ANALYSIS: In our randomized, double-blind, placebo-controlled clinical trial protocol, forty-two patients will be assigned to take either a synbiotic or a placebo capsule for 28 weeks. Both groups will undergo the standard treatment. ETHICS AND DISSEMINATION: The study protocol has been approved by ethics committee of Shahid Beheshti University of Medical Sciences. At the beginning of the study, a written informed consent form will be signed and dated by subjects and investigators. The results will be published in due time.