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.