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NCT02485106

Effect of Gut Decontamination Using Rifaximin in the Patients With Severe Alcoholic Hepatitis

Status unknown Phase 3 Last updated 25 June 2015
What this trial tests

Phase 3 trial testing Rifaximin in Severe Alcoholic Hepatitis in 170 participants. Status unknown.

Timeline
1 July 2015
Primary endpoint
1 December 2016

Quick facts

Lead sponsorSaint Vincent's Hospital, Korea
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment170
Start date1 July 2015
Primary completion1 December 2016

Drugs / interventions tested

Conditions studied

Sponsor

Saint Vincent's Hospital, Korea

Who can join

Adults 19 to 75, any sex, with Severe Alcoholic Hepatitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

This study aimed to investigate the effect of decontamination by rifaximin in severe alcoholic hepatitis patients. Patients who take corticosteroid or pentoxifylline will be randomly allocated to rifaximin group or control group.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Promises of microbiome-based therapies.
    Bajaj JS, Ng SC, Schnabl B. · · 2022 · cited 79× · PMID 35589257 · DOI 10.1016/j.jhep.2021.12.003
  2. Management of decompensated cirrhosis.
    Mansour D, McPherson S. · · 2018 · cited 74× · PMID 29700095 · DOI 10.7861/clinmedicine.18-2-s60
  3. Gut-liver axis and sterile signals in the development of alcoholic liver disease.
    Szabo G, Petrasek J. · · 2017 · cited 56× · PMID 28482064 · DOI 10.1093/alcalc/agx025
  4. Treatment of Severe Alcoholic Hepatitis.
    Thursz M, Morgan TR. · · 2016 · cited 53× · PMID 26948886 · DOI 10.1053/j.gastro.2016.02.074
  5. Gut microbiota-modulating agents in alcoholic liver disease: Links between host metabolism and gut microbiota.
    Jung JH, Kim SE, Suk KT, Kim DJ. · · 2022 · cited 23× · PMID 35935787 · DOI 10.3389/fmed.2022.913842
  6. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis.
    Zacharias HD, Kamel F, Kamel F, Tan J, et al · · 2023 · cited 22× · PMID 37467180 · DOI 10.1002/14651858.cd011585.pub2
  7. Alcohol-Related Liver Disease: An Overview on Pathophysiology, Diagnosis and Therapeutic Perspectives.
    Ha Y, Jeong I, Kim TH. · · 2022 · cited 19× · PMID 36289791 · DOI 10.3390/biomedicines10102530
  8. Emerging medical therapies for severe alcoholic hepatitis.
    Tornai D, Szabo G. · · 2020 · cited 19× · PMID 32981291 · DOI 10.3350/cmh.2020.0145

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