Fecal Microbial Transplantation in Severe Alcoholic Hepatitis (NCT04758806) | Clinical Trial Compass
UnknownPhase 3
Fecal Microbial Transplantation in Severe Alcoholic Hepatitis
Slovakia50 participantsStarted 2018-04-01
Plain-language summary
1. A subtype of Alcoholic hepatitis (AH), named severe alcoholic hepatitis (SAH) is associated with high short-term mortality (J Hepatol, 2019)
2. The only SAH treatment option - corticosteroids (CS) - are often contraindicated or ineffective (STOPAH Trial)
3. New treatment modalities for remaining patients are much needed
4. Fecal microbial transplantation (FMT) is one of the promising therapies
5. Investigators aimed to see if FMT improves survival in patients admitted with SAH, not responding to-, or non-eligible for CS.
Who can participate
Age range
19 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:
* consenting, adult
* severe form of acute alcoholic hepatitis (SAH)
* non-responder to corticosteroids according to the Lille model
* patients with SAH not eligible for corticosteroids based on their contraindications
Exclusion Criteria:
* active infection
* presence of untreated large / high-risk / bleeding esophageal varices
* too sick for any therapy / futility (chronic extrahepatic organ failures, no potential for recovery, etc)
* malignancy except for hepatocellular carcinoma in Milan criteria
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
Mortality
Timeframe: 28-day
2
Mortality
Timeframe: 90-day
3
Mortality
Timeframe: 1 year
Trial details
NCT IDNCT04758806
SponsorF.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica