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Rifaximin in non-alcoholic steatohepatitis: An open-label pilot study

Thursz, Mark R.; Cobbold, Jeremy F.L.; Atkinson, Stephen; Marchesi, Julian R.; Smith, Ann; Wai, Sann N.; Stove, Julie; Yee, Michael S.; Anstee, Quentin M.; Goldin, Robert D.; Taylor-Robinson, Simon D.; Bell, Jimmy D.; Holmes, Elaine; Shojaee-Moradie, Fariba; Thomas, E. Louise; Jackson, Nicola; Fitzpatrick, Julie; Umpleby, A. Margot


Mark R. Thursz

Jeremy F.L. Cobbold

Stephen Atkinson

Julian R. Marchesi

Ann Smith

Sann N. Wai

Julie Stove

Michael S. Yee

Quentin M. Anstee

Robert D. Goldin

Simon D. Taylor-Robinson

Jimmy D. Bell

Elaine Holmes

Fariba Shojaee-Moradie

E. Louise Thomas

Nicola Jackson

Julie Fitzpatrick

A. Margot Umpleby


© 2017 The Japan Society of Hepatology. Aim: Gut microbial dysbiosis is implicated in the pathogenesis of non-alcoholic steatohepatitis (NASH). We investigated downstream effects of gut microbiota modulation on markers of hepatic inflammation, steatosis, and hepatic and peripheral insulin sensitivity in patients with NASH using rifaximin therapy. Methods: Patients with biopsy-proven NASH and elevated aminotransferase values were included in this open-label pilot study, all receiving 6weeks rifaximin 400mg twice daily, followed by a 6-week observation period. The primary endpoint was change in alanine aminotransferase (ALT) after 6weeks of rifaximin. Secondary endpoints were change in hepatic lipid content and insulin sensitivity measured with a hyperinsulinemic–euglycemic clamp. Results: Fifteen patients (13 men and 2 women) with a median (range) age of 46 (32–63)years were included. Seven had diabetes on oral hypoglycemic medications and 8 had no diabetes. After 6weeks of therapy, no differences were seen in ALT (55 [33–191] vs. 63 [41–218]IU/L, P = 0.41), peripheral glucose uptake (28.9 [19.4–48.3] to 25.5 [17.7–47.9]μmol/kg/min, P = 0.30), hepatic insulin sensitivity (35.2 [15.3–51.7]% vs. 30.0 [10.8–50.5]%, P = 0.47), or hepatic lipid content (21.6 [2.2–46.2]% vs. 24.8 [1.7–59.3]%, P = 0.59) before and after rifaximin treatment. After 12weeks from baseline, serum ALT increased to 83 (30–217)IU/L, P = 0.02. There was a significant increase in the homeostasis model assessment–estimated insulin resistance index (P = 0.05). The urinary metabolic profile indicated a significant reduction in urinary hippurate with treatment, which reverted to baseline after cessation of rifaximin, although there was no consistent difference in relative abundance of fecal microbiota with treatment. Conclusion: These data do not indicate a beneficial effect of rifaximin in patients with NASH.


Thursz, M. R., Cobbold, J. F., Atkinson, S., Marchesi, J. R., Smith, A., Wai, S. N., …Umpleby, A. M. (2018). Rifaximin in non-alcoholic steatohepatitis: An open-label pilot study. Hepatology Research, 48(1), 69-77.

Journal Article Type Article
Acceptance Date Apr 8, 2017
Online Publication Date May 31, 2017
Publication Date Jan 1, 2018
Deposit Date Oct 2, 2019
Publicly Available Date Oct 4, 2019
Journal Hepatology Research
Print ISSN 1386-6346
Electronic ISSN 1872-034X
Publisher Wiley
Peer Reviewed Peer Reviewed
Volume 48
Issue 1
Pages 69-77
Keywords Hepatology; Infectious Diseases
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Rifaximin in non-alcoholic steatohepatitis: An open-label pilot study (921 Kb)


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© 2017 The Japan Society of Hepatology. This is the accepted version of the following article: Cobbold, J. F. L., Atkinson, S., Marchesi, J. R., Smith, A., Wai, S. N., Stove, J., Shojaee‐Moradie, F., Jackson, N., Umpleby, A. M., Fitzpatrick, J., Thomas, E. L., Bell, J. D., Holmes, E., Taylor‐Robinson, S. D., Goldin, R. D., Yee, M. S., Anstee, Q. M., and Thursz, M. R. (2018) Rifaximin in non‐alcoholic steatohepatitis: An open‐label pilot study. Hepatol Res, 48: 69–77. doi: 10.1111/hepr.12904, which has been published in final form at

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