Fecal Microbial Transplantation in Severe Alcoholic Hepatitis

Study Overview
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Brief Summary
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A subtype of Alcoholic hepatitis (AH), named severe alcoholic hepatitis (SAH) is associated with high short-term mortality (J Hepatol, 2019) The only SAH treatment option - corticosteroids (CS) - are often contraindicated or ineffective (STOPAH Trial) New treatment modalities for remaining patients are much needed Fecal microbial transplantation (FMT) is one of the promising therapies Investigators aimed to see if FMT improves survival in patients admitted with SAH, not responding to-, or non-eligible for CS.

Detailed Description
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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.

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

Conditions
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Alcoholic Hepatitis

Intervention / Treatment
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* Biological: Fecal microbial transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Eligible for the study are consecutive consenting adult patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecal microbial transplantation from unrelated donor<br>Fecal microbial transplant procured (frozen if needed) from healthy unrelated donors is administered via upper GI tract; predefined single dose is repeated at five consecutive days | Biological: Fecal microbial transplantation<br>* Procured faeces procured from unrelated donor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Overall mortality | 28-day | 
| Mortality | Overall mortality | 90-day | 
| Mortality | Overall mortality | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute on chronic liver failure | Acute on chronic liver failure by European definition | In-Hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcoholic hepatitis, Nonresponders, fecal microbial transplantation