Efficacy of Rifaximin on Hepatosteatosis and Steatohepatitis Patients

Fatty Liver Clinical Trial

Official title:

The Efficacy of Antibiotic Rifaximin on the Lipopolysaccharides (LPS) and Related Cytokine Levels in Non Alcoholic Fatty Liver Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02009592
• Other study ID #: 18245212-108-99/164
• Status: Completed
• Phase: N/A
• First received: November 28, 2013
• Last updated: May 15, 2014
• Start date: June 2013
• Est. completion date: February 2014

Study information

• Verified date: May 2014
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Steatohepatitis

Intervention

Drug:
• Rifaximin
Both arms receive Rifaximin

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Day CP. Non-alcoholic fatty liver disease: current concepts and management strategies. Clin Med (Lond). 2006 Jan-Feb;6(1):19-25. Review. — View Citation

Diamant M, Blaak EE, de Vos WM. Do nutrient-gut-microbiota interactions play a role in human obesity, insulin resistance and type 2 diabetes? Obes Rev. 2011 Apr;12(4):272-81. doi: 10.1111/j.1467-789X.2010.00797.x. Epub 2010 Aug 26. Review. — View Citation

Kalambokis GN, Mouzaki A, Rodi M, Tsianos EV. Rifaximin improves thrombocytopenia in patients with alcoholic cirrhosis in association with reduction of endotoxaemia. Liver Int. 2012 Mar;32(3):467-75. doi: 10.1111/j.1478-3231.2011.02650.x. Epub 2011 Sep 26 — View Citation

Vlachogiannakos J, Saveriadis AS, Viazis N, Theodoropoulos I, Foudoulis K, Manolakopoulos S, Raptis S, Karamanolis DG. Intestinal decontamination improves liver haemodynamics in patients with alcohol-related decompensated cirrhosis. Aliment Pharmacol Ther — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drop in the levels of pro-inflammatory cytokines and increase in anti-inflammatory cytokines	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-a, IL-1 a, IL-6, IL-10 & IL-12 levels.	1 month	No