NCT04758806

Fecal Microbial Transplantation in Severe Alcoholic Hepatitis

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcoholic Hepatitis

Interventions

Type	Name	Description
BIOLOGICAL	Fecal microbial transplantation	Procured faeces procured from unrelated donor

Timeline

• Start date: 2018-04-01
• Primary completion: 2021-12-30
• Completion: 2022-12-30
• First posted: 2021-02-17
• Last updated: 2022-08-03

Locations

1 site across 1 country: Slovakia