Fecal Microbial Transplantation in Severe Alcoholic Hepatitis

Phase 3

• Conditions: Alcoholic Hepatitis
• Interventions: Biological: Fecal microbial transplantation

• Registration Number: NCT04758806
• Lead Sponsor: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

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) - 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.

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 is used with microbiota material procured from unrelated healthy donors.

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-17
• Primary Completion: 2021-12-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fecal microbial transplantation from unrelated donor	Fecal microbial transplantation	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

Primary Outcome Measures

Name	Time	Method
Mortality	1 year	Overall mortality

Secondary Outcome Measures

Name	Time	Method
Acute on chronic liver failure	In-Hospital	Acute on chronic liver failure by European definition

Trial Locations

Locations (1)

F.D.Roosevelt Teaching Hospital; 🇸🇰 Banska Bystrica, Slovakia