Efficacy of Rifaximin on Hepatosteatosis and Steatohepatitis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bezmialem Vakif University
ClinicalTrials.gov Identifier:
NCT02009592
First received: November 28, 2013
Last updated: May 15, 2014
Last verified: May 2014

November 28, 2013
May 15, 2014
June 2013
January 2014   (final data collection date for primary outcome measure)
Drop in the levels of pro-inflammatory cytokines and increase in anti-inflammatory cytokines [ Time Frame: 1 month ] [ Designated as safety issue: No ]
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.
Drop in levels of pro-inflammatory cytokines and increase in anti-inflammatory cytokines [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Before the Rifaximin treatment, serum samples will be obtained in both groups and stored at -80ᵒ C until assays were performed. The levels of serum endotoxins and related pro-inflammatory cytokines (TLR-4, TNF-α, IL-1, IL-6, IL-10 and IL-12) will be measured before and after treatment with Rifaximin 1200 mg/day for 28 days in both groups.
Complete list of historical versions of study NCT02009592 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy of Rifaximin on Hepatosteatosis and Steatohepatitis Patients
The Efficacy of Antibiotic Rifaximin on the Lipopolysaccharides (LPS) and Related Cytokine Levels in Non Alcoholic Fatty Liver Disease Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Fatty Liver
  • Steatohepatitis
Drug: Rifaximin
Both arms receive Rifaximin
Other Name: Colidur 200 mg tablets
  • Active Comparator: Hepatosteatosis
    Rifaximin was given to patients with hepatosteatosis in the doses of 3x2 daily, 200 mg tablets for 4 weeks.
    Intervention: Drug: Rifaximin
  • Active Comparator: Steatohepatitis
    Rifaximin was given to patients with steatohepatitis patients in the doses of 3x2 daily, 200 mg tablets for 4 weeks.
    Intervention: Drug: Rifaximin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
February 2014
January 2014   (final data collection date for primary outcome measure)

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

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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.

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT02009592
18245212-108-99/164
No
Bezmialem Vakif University
Bezmialem Vakif University
Not Provided
Principal Investigator: Hakan Şenturk, Prof. Dr. Director of the Gastroenterology unit
Bezmialem Vakif University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP