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Fecal Microbial Transplantation in Severe Alcoholic Hepatitis (FMTH7)

Primary Purpose

Alcoholic Hepatitis

Status
Recruiting
Phase
Phase 3
Locations
Slovakia
Study Type
Interventional
Intervention
Fecal microbial transplantation
Sponsored by
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholic Hepatitis focused on measuring Alcoholic hepatitis, Nonresponders, fecal microbial transplantation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • F.D.Roosevelt Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fecal microbial transplantation from unrelated donor

Arm 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

Outcomes

Primary Outcome Measures

Mortality
Overall mortality
Mortality
Overall mortality
Mortality
Overall mortality

Secondary Outcome Measures

Acute on chronic liver failure
Acute on chronic liver failure by European definition

Full Information

First Posted
January 21, 2021
Last Updated
August 2, 2022
Sponsor
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
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1. Study Identification

Unique Protocol Identification Number
NCT04758806
Brief Title
Fecal Microbial Transplantation in Severe Alcoholic Hepatitis
Acronym
FMTH7
Official Title
Fecal Microbial Transplantation for Corticosteroids Non-responders and Non-eligible Patients With Severe Alcoholic Hepatitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A subtype of Alcoholic hepatitis (AH), named severe alcoholic hepatitis (SAH) is associated with high short-term mortality (J Hepatol, 2019) The only SAH treatment option - corticosteroids (CS) - are often contraindicated or ineffective (STOPAH Trial) New treatment modalities for remaining patients are much needed Fecal microbial transplantation (FMT) is one of the promising therapies 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Hepatitis
Keywords
Alcoholic hepatitis, Nonresponders, fecal microbial transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Eligible for the study are consecutive consenting adult patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fecal microbial transplantation from unrelated donor
Arm Type
Experimental
Arm 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
Intervention Type
Biological
Intervention Name(s)
Fecal microbial transplantation
Intervention Description
Procured faeces procured from unrelated donor
Primary Outcome Measure Information:
Title
Mortality
Description
Overall mortality
Time Frame
28-day
Title
Mortality
Description
Overall mortality
Time Frame
90-day
Title
Mortality
Description
Overall mortality
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Acute on chronic liver failure
Description
Acute on chronic liver failure by European definition
Time Frame
In-Hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lubomir Skladany, MD,PhD
Phone
+421905482997
Email
lubomir.skladany@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia Bystrianska, MD
Phone
+421917944393
Email
naty2121@centrum.sk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lubomir Skladany, MD, PhD
Organizational Affiliation
Head Dept Internal Medicine F.D.Roosevelt Teaching Hospital Banska Bystrica Slovakia
Official's Role
Principal Investigator
Facility Information:
Facility Name
F.D.Roosevelt Teaching Hospital
City
Banska Bystrica
ZIP/Postal Code
97401
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lubomir Skladany, MD, PhD
Phone
+421905482997
Email
lubomir.skladany@gmail.com
First Name & Middle Initial & Last Name & Degree
Natalia Bystrianska, MD
Phone
+421917944393
Email
naty2121@centrum.sk
First Name & Middle Initial & Last Name & Degree
Daniela Jancekova, MD
First Name & Middle Initial & Last Name & Degree
Janka Vnencakova, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
On request by institution of interest, e.g. on submission to medical journal / by editorial office; by auditing authority
IPD Sharing Time Frame
First release of results is expected in 2021, final analysis in 2022
IPD Sharing Access Criteria
General Data Protection Regulation (GDPR) compliance Editorial office approved member Auditing authority Authors, meta analysis / systematic review
IPD Sharing URL
http://www.fnspfdr.sk

Learn more about this trial

Fecal Microbial Transplantation in Severe Alcoholic Hepatitis

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