Antifibrotic and molecular aspects of rifaximin in alcoholic liver disease: study protocol for a randomized controlled trial

Trials
Bjørn Stæhr MadsenAleksander Krag

Abstract

Alcoholic liver disease is the leading cause of cirrhosis worldwide. Due to an increase in alcohol overuse, alcoholic liver disease has become an increased burden on health care systems. Abstinence from alcohol remains the cornerstone of alcoholic liver disease treatment; however, this approach is hampered by frequent relapse and lack of specific therapy for treating advanced cases of liver disease. In the present study, we hypothesized that gut microbiota drive the development of liver fibrosis and that modulation of gut microbiota with the gut-selective, nonabsorbable antibiotic rifaximin attenuates alcoholic liver fibrosis. Our double-blind, placebo-controlled trial will include 136 participants with biopsy-verified alcoholic fibrosis (Ishak liver fibrosis score of 1-4). Participants are randomized 1:1 to receive placebo or 550 mg of rifaximin twice daily for 18 months. A liver biopsy will be performed at the end of the treatment period to evaluate the effect of drug treatment on liver fibrosis. Stool, urine, and saliva specimens will be collected before treatment begins, at 1 month, and at the end of the treatment period. Fecal samples are used for microbiome deep sequencing. Changes in microbiome composition are compared b...Continue Reading

References

Nov 25, 2003·Alcoholism, Clinical and Experimental Research·Charles S LieberUNKNOWN Veterans Affairs Cooperative Study 391 Group
Nov 25, 2003·Alcoholism, Clinical and Experimental Research·Charles S LieberUNKNOWN Veterans Affairs Cooperative Study 391 Group
May 28, 2005·Expert Review of Anti-infective Therapy·Laura GerardHerbert L DuPont
Oct 24, 2007·Nature Medicine·Ekihiro SekiRobert F Schwabe
Mar 26, 2010·The New England Journal of Medicine·Nathan M BassWilliam P Forbes
May 1, 2010·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Vijay H Shah
Jun 16, 2010·Gastroenterology·Joe West, Timothy R Card
Jul 25, 2013·Advances in Therapy·Bjørn S MadsenAleksander Krag
Nov 12, 2013·Lancet·Roger Williams, Richard Horton
Dec 3, 2014·Gastroenterology·Gyongyi Szabo
Apr 16, 2015·Alcoholism, Clinical and Experimental Research·Phillipp HartmannBernd Schnabl
Apr 29, 2015·Journal of Hepatology·Philippe Mathurin, Ramon Bataller
Dec 1, 2015·Alimentary Pharmacology & Therapeutics·H L DuPont
Jul 4, 2017·Journal of Gastroenterology and Hepatology·Nina KimerUNKNOWN members of the CoRif study group
Oct 3, 2017·Nature Biotechnology·Paul I CosteaPeer Bork

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Citations

Oct 23, 2018·Visceral Medicine·Jonel TrebickaWim Laleman
Sep 22, 2019·International Journal of Molecular Sciences·Marica MeroniPaola Dongiovanni
Jan 10, 2021·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Paolo CaraceniUNKNOWN Liverhope Consortium

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Methods Mentioned

BETA
biopsies
biopsy
contraception
pregnancy test

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