Effects of Rifaximin in Patients With Acute Alcoholic Hepatitis (NCT02116556) | Clinical Trial Compass
UnknownPhase 2
Effects of Rifaximin in Patients With Acute Alcoholic Hepatitis
Spain29 participantsStarted 2013-04
Plain-language summary
Acute alcoholic hepatitis (AAH) is a serious condition and one of the most frequent causes of Acute-on-Chronic Liver Failure. The current standard therapy (corticosteroids) is theme of debate and unsatisfactory in many patients (year mortality: 30%). One of the main causes of death is bacterial infections, which affect 40-50% of patients at 90 days. Intestinal decontamination with rifaximin (a nonabsorbable antibiotic) reduces endotoxemia, improves liver function and reduces the complications of decompensated alcoholic cirrhosis.
The Hypothesis/Objective: To assess whether oral decontamination with rifaximin prevents the development of infections associated with AAH and analyze its consequences.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients ≥18 and \<70 years of age.
* Active alcohol abuse and excessive alcohol consumption prior to admission defined as \> 50 g per day for men and\> 40 g per day for women.
* Jaundice (Bilirubin \>2 mg/dl) for no more than 3 months.
* Clinical suspicion of Alcoholic Hepatitis with a modified Maddrey's Discriminant Function \> 32 points.
Exclusion Criteria:
* Hypersensitivity to Rifaximin
* Advanced Chronic or Terminal illness. Advanced Chronic illness will be defined as: all conditions evolved into a clinical stage to limit the patient's functional status (eg, heart failure NYHA\> II, COPD PCO2\> 50 mmHg or PO2 \<60 mmHg, stroke or other disabling neurological disease, disabling or uncontrolled oncological conditions, etc ...).
Terminal illness will be defined as any clinical conditions with a survival expectancy less than 3 months
* Hepatocellular carcinoma (previously diagnosed) beyond Milan's criteria.
* Complete portal vein thrombosis (previously diagnosed).
* Autoimmune liver disease.
* Hepatitis B and C and HIV infection (anti-HCV, surface HBV antigen and anti-HIV positive).
* Pregnancy or nursing.
* Use of Rifaximin during the previous 2 months.
* Treatment with Pentoxifylline.
* Lack of informed consent.
Removal criteria:
* Lack of histological confirmation of Alcoholic Hepatitis during the first 7 days after inclusion.
Because there are no non-diagnostic tools to diagnose alcoholic hepatitis, histological confirmation is required in …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of bacterial infections
Timeframe: 90 days
Trial details
NCT IDNCT02116556
SponsorHospital Universitari Vall d'Hebron Research Institute