Efficacy of Rifaximin on Hepatosteatosis and Steatohepatitis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fatty Liver Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hepatosteatosis

Rifaximin was given to patients with hepatosteatosis in the doses of 3x2 daily, 200 mg tablets for 4 weeks.

Group Type ACTIVE_COMPARATOR

Rifaximin

Intervention Type DRUG

Both arms receive Rifaximin

Steatohepatitis

Rifaximin was given to patients with steatohepatitis patients in the doses of 3x2 daily, 200 mg tablets for 4 weeks.

Group Type ACTIVE_COMPARATOR

Rifaximin

Intervention Type DRUG

Both arms receive Rifaximin

Interventions

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Rifaximin

Both arms receive Rifaximin

Intervention Type DRUG

Other Intervention Names

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Colidur 200 mg tablets

Eligibility Criteria

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Inclusion Criteria

\-

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No