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Efficacy of Rifaximin on Hepatosteatosis and Steatohepatitis Patients

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ClinicalTrials.gov Identifier: NCT02009592
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : May 16, 2014
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Fatty Liver Steatohepatitis Drug: Rifaximin

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Antibiotic Rifaximin on the Lipopolysaccharides (LPS) and Related Cytokine Levels in Non Alcoholic Fatty Liver Disease Patients
Study Start Date : June 2013
Primary Completion Date : January 2014
Study Completion Date : February 2014

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Hepatosteatosis
Rifaximin was given to patients with hepatosteatosis in the doses of 3x2 daily, 200 mg tablets for 4 weeks.
Drug: Rifaximin
Both arms receive Rifaximin
Other Name: Colidur 200 mg tablets
Active Comparator: Steatohepatitis
Rifaximin was given to patients with steatohepatitis patients in the doses of 3x2 daily, 200 mg tablets for 4 weeks.
Drug: Rifaximin
Both arms receive Rifaximin
Other Name: Colidur 200 mg tablets

Outcome Measures

Primary Outcome Measures :
  1. Drop in the levels of pro-inflammatory cytokines and increase in anti-inflammatory cytokines [ Time Frame: 1 month ]
    Rifaximin treatment to both patient groups at the dose of 1200 mg/daily for 28 days. Blood samples obtain from all patients at 0 day, 14th day, 28th day and 60th day and collect serum for the analysis of the endotoxins and pro-inflammatory cytokines -TLR-4, TNF-α, IL-1 α, IL-6, IL-10 & IL-12 levels.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:Patients between the ages of 18-70, irrespective of gender referred to the gastroenterology clinics for persistently elevated liver enzymes, obesity, T2DM (Type 2 diabetes mellitus) and clinical suspicion of NAFLD selected for this study

Exclusion Criteria:

Allergy for Rifaximin, pregnant women and lactating women, other liver diseases such as viral hepatitis, autoimmune liver diseases, drug induced liver diseases, pancreas-biliary tract and liver-related documented diseases (pancreatitis, stone pouch on the biliary colic pains, acute cholecystitis, choledocholithiasis, hepatobiliary cancers etc.,). Hit-defined psychiatric illness, excessive alcohol intake (who consume >20g/day ) were excluded from this study.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009592

Bezmialem Vakif University
Istanbul, Turkey, 34093
Sponsors and Collaborators
Bezmialem Vakif University
Principal Investigator: Hakan Şenturk, Prof. Dr. Director of the Gastroenterology unit
More Information

Responsible Party: Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT02009592     History of Changes
Other Study ID Numbers: 18245212-108-99/164
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: May 2014

Keywords provided by Bezmialem Vakif University:
Inflammatory cytokines

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents