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Clinical Trials/NCT04758806
NCT04758806UnknownPhase 3

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

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica2 sites in 1 country50 target enrollmentStarted: April 1, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Sponsor
Enrollment
50
Locations
2
Primary Endpoint
Mortality
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Mortality

Time Frame: 1 year

Overall mortality

Secondary Outcomes

  • Acute on chronic liver failure(In-Hospital)

Investigators

Sponsor
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ľubomír Skladaný MD, PhD

Head, Department of Internal Medicine and HEGITO Liver Unit, Principal Investigator

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Study Sites (2)

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