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Fecal Microbial Transplantation in Severe Alcoholic Hepatitis — FMTH7  

Alcoholic Hepatitis Clinical Trial

Official title:
Fecal Microbial Transplantation for Corticosteroids Non-responders and Non-eligible Patients With Severe Alcoholic Hepatitis

Clinical Trial 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.

Clinical Trial 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 is used with microbiota material procured from unrelated healthy donors. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04758806
Study type Interventional
Source F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Contact Lubomir Skladany, MD,PhD
Phone +421905482997
Email lubomir.skladany@gmail.com
Status Recruiting
Phase Phase 3
Start date April 1, 2018
Completion date December 30, 2022
View Details
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