FMTH7: Fecal Microbial Transplantation in Severe Alcoholic Hepatitis

Sponsor

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica (Other)

Overall Status

Recruiting

CT.gov ID

NCT04758806

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholic Hepatitis	Biological: Fecal microbial transplantation	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Eligible for the study are consecutive consenting adult patientsEligible for the study are consecutive consenting adult patients

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2018

Actual Primary Completion Date :

Dec 30, 2021

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fecal microbial transplantation from unrelated donor 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 Procured faeces procured from unrelated donor

Arm

Intervention/Treatment

Experimental: Fecal microbial transplantation from unrelated donor

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

Procured faeces procured from unrelated donor

Outcome Measures

Primary Outcome Measures

Mortality [28-day]
Overall mortality
Mortality [90-day]
Overall mortality
Mortality [1 year]
Overall mortality

Secondary Outcome Measures

Acute on chronic liver failure [In-Hospital]
Acute on chronic liver failure by European definition

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	F.D.Roosevelt Teaching Hospital	Banska Bystrica		Slovakia	97401

Sponsors and Collaborators

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Investigators

Principal Investigator: Lubomir Skladany, MD, PhD, Head Dept Internal Medicine F.D.Roosevelt Teaching Hospital Banska Bystrica Slovakia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ľubomír Skladaný MD, PhD, Head, Department of Internal Medicine and HEGITO Liver Unit, Principal Investigator, F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

ClinicalTrials.gov Identifier:

NCT04758806

Other Study ID Numbers:

432/2018-IK

First Posted:

Feb 17, 2021

Last Update Posted:

Aug 3, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ľubomír Skladaný MD, PhD, Head, Department of Internal Medicine and HEGITO Liver Unit, Principal Investigator, F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Alcoholic hepatitis

Nonresponders

fecal microbial transplantation

Additional relevant MeSH terms:

Hepatitis A

Hepatitis

Hepatitis, Alcoholic

Study Results

No Results Posted as of Aug 3, 2022