Fecal Microbial Transplantation in Severe Alcoholic Hepatitis

Alcoholic Hepatitis Clinical Trial

— FMTH7  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04758806
• Other study ID #: 432/2018-IK
• Status: Recruiting
• Phase: Phase 3
• Start date: April 1, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2022
• Source: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
• Contact: Lubomir Skladany, MD,PhD
• Phone: +421905482997
• Email: lubomir.skladany[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcoholic Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic

Intervention

Biological:
• Fecal microbial transplantation
Procured faeces procured from unrelated donor

Locations

Country	Name	City	State
Slovakia	F.D.Roosevelt Teaching Hospital	Banska Bystrica

Sponsors (1)

Lead Sponsor	Collaborator
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Overall mortality	28-day
Primary	Mortality	Overall mortality	90-day
Primary	Mortality	Overall mortality	1 year
Secondary	Acute on chronic liver failure	Acute on chronic liver failure by European definition	In-Hospital