NCT04758806

Brief Summary

  1. 1.A subtype of Alcoholic hepatitis (AH), named severe alcoholic hepatitis (SAH) is associated with high short-term mortality (J Hepatol, 2019)
  2. 2.The only SAH treatment option - corticosteroids (CS) - are often contraindicated or ineffective (STOPAH Trial)
  3. 3.New treatment modalities for remaining patients are much needed
  4. 4.Fecal microbial transplantation (FMT) is one of the promising therapies
  5. 5.Investigators aimed to see if FMT improves survival in patients admitted with SAH, not responding to-, or non-eligible for CS.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2018

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

3.8 years

First QC Date

January 21, 2021

Last Update Submit

August 2, 2022

Conditions

Alcoholic Hepatitis

Keywords

Alcoholic hepatitisNonrespondersfecal microbial transplantation

Outcome Measures

Primary Outcomes (3)

  • Mortality

    Overall mortality

    28-day

  • Mortality

    Overall mortality

    90-day

  • Mortality

    Overall mortality

    1 year

Secondary Outcomes (1)

  • Acute on chronic liver failure

    In-Hospital

Study Arms (1)

Fecal microbial transplantation from unrelated donor

EXPERIMENTAL

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

Interventions

Fecal microbial transplantationBIOLOGICAL

Procured faeces procured from unrelated donor

Fecal microbial transplantation from unrelated donor

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

F.D.Roosevelt Teaching Hospital

Banská Bystrica, 97401, Slovakia

RECRUITING

MeSH Terms

Conditions

Hepatitis, Alcoholic

Condition Hierarchy (Ancestors)

HepatitisLiver DiseasesDigestive System DiseasesLiver Diseases, AlcoholicAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Lubomir Skladany, MD, PhD

    Head Dept Internal Medicine F.D.Roosevelt Teaching Hospital Banska Bystrica Slovakia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lubomir Skladany, MD,PhD

CONTACT

+421905482997lubomir.skladany@gmail.com

Natalia Bystrianska, MD

CONTACT

+421917944393naty2121@centrum.sk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Eligible for the study are consecutive consenting adult patients
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Department of Internal Medicine and HEGITO Liver Unit, Principal Investigator

Study Record Dates

First Submitted

January 21, 2021

First Posted

February 17, 2021

Study Start

April 1, 2018

Primary Completion

December 30, 2021

Study Completion

December 30, 2022

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

On request by institution of interest, e.g. on submission to medical journal / by editorial office; by auditing authority

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
First release of results is expected in 2021, final analysis in 2022
Access Criteria
General Data Protection Regulation (GDPR) compliance Editorial office approved member Auditing authority Authors, meta analysis / systematic review
More information

Locations

SL(1)