Abstract
BackgroundNon-alcohol fatty liver disease (NAFLD) is the most common chronic liver disease in the world, with a high incidence and no effective treatment. At present, the targeted therapy of intestinal microbes for NAFLD is highly valued. Lycium barbarum polysaccharide (LBP), as the main active ingredient of Lycium barbarum, is considered to be a new type of prebiotic substance, which can improve NAFLD by regulating the gut microbiota. The purpose of this study is to evaluate the safety and efficacy of LBP supplementation in modulating gut microbiota for NAFLD patients.MethodsThis randomized, double-blind, placebo-control study will be conducted in the physical examination center of the Ningxia Hui Autonomous Region People’s Hospital. A total of 50 patients with NAFLD confirmed by abdominal ultrasound, laboratory tests, and questionnaire surveys will be recruited and randomly assigned into the control group (maltodextrin placebo capsules) and the intervention group (LBP supplementation capsules) for 3 months. Neither patients, nor investigators, nor data collectors will know the contents in each capsule and the randomization list. The primary outcome measure is the level of ALT concentration relief after the intervention. Secondary outcomes include gut microbiota abundance and diversity, intestinal permeability, patient’s characteristic demographic data and body composition, adverse effects, and compliance from patients.DiscussionLBPs are potential prebiotics with the property of regulating host gut microbiota. Our previous studies have documented that LBP supplement can improve the liver damage and the gut microflora dysbiosis in NAFLD rats. This treatment would provide a more in-depth understanding of the effect of this LBP supplementation.Trial registrationChinese Clinical Trial Register, ChiCTR2000034740. Registered on 17 July 2020.
Highlights
Non-alcohol fatty liver disease (NAFLD) is the most common chronic liver disease in the world, with a high incidence and no effective treatment
Recent study from Zhu et al [19] found that Lycium barbarum polysaccharides (LBPs) from Goji berry have prebiotic activities which can stimulate beneficial bacteria growth in vitro, balancing the microbial composition in gut, enhancing the bacteria concentration and immunity in mice. These results indicate that LBPs are potential prebiotics with the property of regulating host gut microbiota
Despite the tremendous progress made in studying the pathogenesis of NAFLD, the main factors leading to the evolution of NAFLD from simple steatosis (NAFL) to non-alcoholic steatohepatitis (NASH) have been largely unknown
Summary
Non-alcohol fatty liver disease (NAFLD) is the most common chronic liver disease in the world, with a high incidence and no effective treatment. Lycium barbarum polysaccharide (LBP), as the main active ingredient of Lycium barbarum, is considered to be a new type of prebiotic substance, which can improve NAFLD by regulating the gut microbiota. Non-alcoholic fatty liver disease (NAFLD) is characterized by the presence of fat accumulation more than 5% in hepatocytes, which is not due to hepatitis B virus (HBV) or hepatitis C virus (HCV) infection and excessive alcohol consumption. It is a chronic and wide spectrum of liver disease, involving a complex. The mechanism of pathogenesis and progression of NAFLD is multifactorial and complex and there are no approved pharmacological therapies for the treatment of NAFLD up to now [5]
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