Efficacy of Rifaximin on Hepatosteatosis and Steatohepatitis Patients
Condition: Fatty Liver; Steatohepatitis
MeSH terms: Fatty Liver
Study type: Interventional

Summary: 
      Non alcoholic fatty liver disease (NAFLD) is a common cause of chronic liver disease, it
      encompasses from simple steatosis to non alcoholic steatohepatitis (NASH) and, eventually
      leads to cirrhosis and hepatocellular carcinoma (HCC). Dysbiosis, over nutrition, life style,
      type 2 diabetes (T2DM) and metabolic syndrome are main causes in the disease progression.
      Research on the role of gut-liver axis in the pathogenesis of NAFLD has been slowly
      accumulating over the past few years. Endotoxemia resulting from intestinal bacterial
      overgrowth may contribute to the pathogenesis of NAFLD. So, intestinal microbiota (IM) serve
      as a potential therapeutic target in NASH. In this regard, we have aimed to test the efficacy
      of rifaximin against simple steatosis (NAFLD) and steatohepatitis (NASH) subjects in relation
      to serum endotoxins and related pro-inflammatory cytokine levels. We hypothesis that
      Rifaximin treatment may influence the endotoxin levels by modulating gut microbiota and
      partial alleviate from NAFLD/NASH.
    

Detailed description: 
      Study area:

      This prospective study conducted from July 2013 to March 2014 at Bezmialem Vakif University
      School of Medicine in the Department of Gastroenterology.

      Subjects and methods:

      Patients between the ages of 18-70, irrespective of gender referred to the gastroenterology
      clinics for persistently elevated liver enzymes, obesity, type 2 diabetes mellitus (T2DM) and
      clinical suspicion of NAFLD selected for this study. During the initial visit, patients are
      invited to participate in this study. After providing written informed consent, these
      patients received a detailed medical history, physical examination, Age, sex, BMI, waist
      circumference and appropriate laboratory tests will be made. Ultrasonography (US) examination
      takes place before biopsy.

      Endotoxins and Pro-Inflammatory cytokine assays:

      These assays are going to perform by using following ELISA kits. Tumour necrosis factor
      (TNF)-α, interleukin (IL)-1, IL-6, IL-10 and IL-12 obtained from EBIOSCİENCE company. LAL
      chromogenic end point assay kit obtained from HYCULT company and toll like receptor (TLR)-4
      assay kit obtained from USCN company.

      Statistical Analysis:

      Statistical calculations 'Statistical Package for Social Sciences' (SPSS) software package
      for Windows 16 computer program was used. Descriptive statistics when numeric data as mean ±
      standard deviation, proportional data were used as the number and percentage rates.
      Independent samples t-test to compare the groups, and the chi-square and Mann-Whitney U tests
      were used for statistical analysis. P <0.05 will be considered as the limit of statistical
      significance.
    

Intervention name(s): Rifaximin
Intervention type(s): Drug
Intervention description(s): Both arms receive Rifaximin
Other intervention name(s): Colidur 200 mg tablets
Intervention MeSH terms: Rifaximin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatosteatosis; Steatohepatitis; Rifaximin; Inflammatory cytokines