Status:
UNKNOWN
Fecal Microbial Transplantation in Severe Alcoholic Hepatitis
Lead Sponsor:
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Conditions:
Alcoholic Hepatitis
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief 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) ...
Detailed Description
* FMT via upper GI tract is provided to CS non-responders (NR) or non-eligible (NE) adult patients hospitalized with SAH (determined by the Lille-model). * Modified version of the Sarin FMT protocol i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04758806
Start Date
April 1 2018
End Date
December 30 2022
Last Update
August 3 2022
Active Locations (1)
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1
F.D.Roosevelt Teaching Hospital
Banská Bystrica, Slovakia, 97401