Fecal Microbial Transplantation in Severe Alcoholic Hepatitis
Sponsored by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
About this trial
Last updated 3 years ago
Study ID
432/2018-IK
Status
Recruiting
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
19+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 3 years ago
What is this trial about?
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.
What are the participation requirements?
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
Locations
Location
Status
Recruiting