Fecal Microbial Transplantation in Severe Alcoholic Hepatitis (FMTH7)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Alcoholic Hepatitis
• Intervention / Treatment: Biological: Fecal microbial transplantation

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Lubomir Skladany, MD,PhD; Phone Number: +421905482997; Email: lubomir.skladany@gmail.com

Study Locations

• Slovakia
  • Banska Bystrica, Slovakia, 97401
    • Recruiting
    • F.D.Roosevelt Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): December 30, 2021
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Alcoholic hepatitis; Nonresponders; fecal microbial transplantation
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; RNA Virus Infections; Virus Diseases; Infections; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Hepatitis; Hepatitis A; Hepatitis, Alcoholic
• Other Study ID Numbers: 432/2018-IK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: On request by institution of interest, e.g. on submission to medical journal / by editorial office; by auditing authority
• IPD Sharing Time Frame: First release of results is expected in 2021, final analysis in 2022
• IPD Sharing Access Criteria: General Data Protection Regulation (GDPR) compliance Editorial office approved member Auditing authority Authors, meta analysis / systematic review
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No