Fecal Microbial Transplantation in Severe Alcoholic Hepatitis

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04758806

Acronym

FMTH7

Enrollment

Registered

2021-02-17

Start date

2018-04-01

Completion date

2022-12-30

Last updated

2022-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic Hepatitis

Keywords

Alcoholic hepatitis, Nonresponders, fecal microbial transplantation

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.

Interventions

BIOLOGICALFecal microbial transplantation

Procured faeces procured from unrelated donor

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Eligible for the study are consecutive consenting adult patients

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Mortality	28-day	Overall mortality

Secondary

Measure	Time frame	Description
Acute on chronic liver failure	In-Hospital	Acute on chronic liver failure by European definition

Countries

Slovakia

Contacts

Primary ContactLubomir Skladany, MD,PhD

lubomir.skladany@gmail.com+421905482997

Backup ContactNatalia Bystrianska, MD

naty2121@centrum.sk+421917944393

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026