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Rifaximin Use in Severe Alcoholic Hepatitis

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02485106
Enrollment
170
Registered
2015-06-30
Start date
2015-07-31
Completion date
Unknown
Last updated
2015-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Alcoholic Hepatitis

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.

Interventions

DRUGRifaximin

400mg three times per day for 28 days

DRUGCorticosteroid or pentoxifylline

Corticosteroid 40mg/day or pentoxifylline 400mg three times per day for 28 days

Sponsors

Saint Vincent's Hospital, Korea
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Mortality6-month

Contacts

Primary ContactDo Seon Song
dsman@catholic.ac.kr82-31-249-8204

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026