Efficacy of Rifaximin on Hepatosteatosis and Steatohepatitis Patients

NCT02009592 | Completed

• 1 other identifier: 18245212-108-99/164
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatty Liver; Steatohepatitis

Keywords

Hepatosteatosis; Steatohepatitis; Rifaximin; Inflammatory cytokines

Outcome Measures

Primary Outcomes (1)

• 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-α, IL-1 α, IL-6, IL-10 \& IL-12 levels.

  1 month

Study Arms (2)

Hepatosteatosis

ACTIVE COMPARATOR

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

Drug: Rifaximin

Steatohepatitis

ACTIVE COMPARATOR

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

Drug: Rifaximin

Interventions

Rifaximin DRUG

Both arms receive Rifaximin

Also known as: Colidur 200 mg tablets

Hepatosteatosis; Steatohepatitis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (4)

• Day CP. Non-alcoholic fatty liver disease: current concepts and management strategies. Clin Med (Lond). 2006 Jan-Feb;6(1):19-25. doi: 10.7861/clinmedicine.6-1-19.

  PMID: 16521351 RESULT

• 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.

  PMID: 22098272 RESULT

• 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. 2009 May 1;29(9):992-9. doi: 10.1111/j.1365-2036.2009.03958.x. Epub 2009 Feb 7.

  PMID: 19210289 RESULT

• 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.

  PMID: 20804522 RESULT

MeSH Terms

Conditions

Fatty Liver

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Hakan Şenturk, Prof. Dr.

  Director of the Gastroenterology unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2013
• First Posted: December 12, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 16, 2014

Record last verified: 2014-05

Locations

TU (1)