Rifaximin Use in Severe Alcoholic Hepatitis
Effect of Gut Decontamination Using Rifaximin in the Patients With Severe Alcoholic Hepatitis
1 other identifier
interventional
170
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2015
CompletedFirst Posted
Study publicly available on registry
June 30, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedJune 30, 2015
June 1, 2015
1.4 years
June 24, 2015
June 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality
6-month
Study Arms (2)
Rifaximin group
ACTIVE COMPARATORCorticosteroid or Pentoxifylline for 28 days Rifaximin 400mg tid for 28 days
Control group
ACTIVE COMPARATORCorticosteroid or Pentoxifylline for 28 days
Interventions
Corticosteroid 40mg/day or pentoxifylline 400mg three times per day for 28 days
Eligibility Criteria
You may qualify if:
- Heavy alcohol drinking within 3 months (Over 40 g/day)
- Maddrey's discriminant function ≥ 32
- AST/ALT ration ≥ 2
- Bilirubin level ≥ 5mg/dL
- Any one of the following additional criteria : hepatic encephalopathy, enlarged, tender liver, or peripheral leucocytosis
- Age : 19-75
- Jaundice within 3 months
You may not qualify if:
- Other causes of chronic liver disease (HBV, HCV, or autoimmune hepatitis)
- Antibiotics or probiotics use within 8 weeks
- Drug induced hepatotoxicity
- Acute viral hepatitis (HAV or HEV)
- Hepatic abscess or cholagitis
- Hepatocellular carcinoma of modified UICC stage II, III or IV
- Malignant tumor other than HCC
- Pregnancy
- Severe chronic extrahepatic disease
- Type I hepatorenal syndrome
- Hepatic encephalopathy grade II or IV
- Severe infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Song DS, Yang JM, Jung YK, Yim HJ, Kim HY, Kim CW, Kim SS, Cheong JY, Lee HL, Lee SW, Yoo JJ, Kim SG, Kim YS. Rifaximin treatment in patients with severe alcohol-associated hepatitis: A multicenter, randomized controlled, open-label, pilot trial. Ann Hepatol. 2025 Jan-Jun;30(1):101749. doi: 10.1016/j.aohep.2024.101749. Epub 2024 Dec 9.
PMID: 39662593DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical assistant professor
Study Record Dates
First Submitted
June 24, 2015
First Posted
June 30, 2015
Study Start
July 1, 2015
Primary Completion
December 1, 2016
Last Updated
June 30, 2015
Record last verified: 2015-06