Fecal Microbial Transplantation in Severe Alcoholic Hepat... | NCT04758806

Studies
Fecal Microbial Transplantation in Severe Alcoholic Hepatitis

NCT04758806

Sponsor

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Status

Unknown status

Last Update Posted

Aug 3, 2022Actual

Enrollment

50Estimated

Phase

Phase 3

Conditions

Alcoholic Hepatitis

Interventions

Fecal microbial transplantation

Countries

Slovakia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2018Actual

Primary Completion Date

Dec 30, 2021Actual

Completion Date

Dec 30, 2022Estimated

First Submitted Date

Jan 21, 2021

First Submission Date that Met QC Criteria

Feb 15, 2021

First Posted Date

Feb 17, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2022

Last Update Posted Date

Aug 3, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ľubomír Skladaný MD, PhD, Head, Department of Internal Medicine and HEGITO Liver Unit, Principal Investigator, F.D. Roosevelt Teaching Hospital with Policlinic Banska BystricaPrincipal Investigator

Lead Sponsor

F.D. Roosevelt Teaching Hospital with Policlinic Banska BystricaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Fecal microbial transplantation	Biological	Procured faeces procured from unrelated donor	Fecal microbial transplantation from unrelated donor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Overall mortality	28-day
Mortality	Overall mortality	90-day
Mortality	Overall mortality	1 year

Secondary Outcomes

Measure	Description	Time Frame
Acute on chronic liver failure	Acute on chronic liver failure by European definition	In-Hospital

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lubomir Skladany, MD,PhD	Contact	+421905482997		lubomir.skladany@gmail.com
Natalia Bystrianska, MD	Contact	+421917944393		naty2121@centrum.sk

Overall Officials

Name	Affiliation	Role
Lubomir Skladany, MD, PhD	Head Dept Internal Medicine F.D.Roosevelt Teaching Hospital Banska Bystrica Slovakia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
F.D.Roosevelt Teaching Hospital	Recruiting	Banská Bystrica		97401	Slovakia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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

URL

http://www.fnspfdr.sk

Condition Browse Module

MeSH Terms

ID	Term
D006519	Hepatitis, Alcoholic

Ancestor Terms

ID	Term
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D008108	Liver Diseases, Alcoholic

Browse Leaves

Not provided

Browse Branches

Not provided