Fecal Microbial Transplantation in Severe Alcoholic Hepatitis (FMTH7)

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Status and phase: Enrolling; Phase 3

Conditions: Alcoholic Hepatitis

Treatments: Biological: Fecal microbial transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04758806

432/2018-IK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Fecal microbial transplantation from unrelated donor

Experimental group

Description:

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

Treatment:

Biological: Fecal microbial transplantation