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Status unknownNCT04758806FMTH7Updated Aug 3, 2022

Fecal Microbial Transplantation in Severe Alcoholic Hepatitis

A Phase 3 interventional study of Fecal microbial transplantation in Alcoholic Hepatitis, sponsored by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica. Status unknown at 1 site in Slovakia. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-08-03.

Sponsored by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Apr 2018, registered Jan 2021).
Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study 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.
Read the 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.
02

Conditions studied

  • Alcoholic Hepatitis

Browse trials for

Keywords

  • Alcoholic hepatitis
  • Nonresponders
  • fecal microbial transplantation
03

In context

Hepatitis, Alcoholic

108 studies on the registry are indexed under Hepatitis, Alcoholic; 23 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 76 interventional studies indexed under Hepatitis, Alcoholic.

Browse Hepatitis, Alcoholic studies →

Lead sponsor

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Fecal microbial transplantation from unrelated donor

    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

06

What researchers measure

Primary outcomes

  1. Mortality

    Overall mortality

    Time frame: 28-day

  2. Mortality

    Overall mortality

    Time frame: 90-day

  3. Mortality

    Overall mortality

    Time frame: 1 year

Secondary outcomes

  1. Acute on chronic liver failure

    Acute on chronic liver failure by European definition

    Time frame: In-Hospital

07

Study locations

1 of 1 sites recruiting
  • F.D.Roosevelt Teaching Hospital
    Banská Bystrica, 97401, Slovakia
    • Lubomir Skladany, MD, PhD · Contact · lubomir.skladany@gmail.com · +421905482997
    • Natalia Bystrianska, MD · Contact · naty2121@centrum.sk · +421917944393
    • Daniela Jancekova, MD · Sub investigator
    • Janka Vnencakova, MD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

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

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

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

Data sharing details ↗ · www.fnspfdr.sk

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2018 to primary completion in Dec 2021, 44 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 21, 2021
First posted
Feb 17, 2021
StartActual
Apr 1, 2018
Primary completionActual
Dec 30, 2021
CompletionEst.
Dec 30, 2022
Last update
Aug 3, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04758806
Lead sponsor
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Responsible party
Ľubomír Skladaný MD, PhD (Head, Department of Internal Medicine and HEGITO Liver Unit, Principal Investigator, F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica) — Principal investigator
First posted
Feb 17, 2021
Start date
Apr 1, 2018
Primary completion
Dec 30, 2021
Completion
Dec 30, 2022 (estimated)
Last update
Aug 3, 2022

Study contacts

Lubomir Skladany, MD,PhD
Contact
lubomir.skladany@gmail.com
+421905482997
Natalia Bystrianska, MD
Contact
naty2121@centrum.sk
+421917944393
Lubomir Skladany, MD, PhD
principal investigator · Head Dept Internal Medicine F.D.Roosevelt Teaching Hospital Banska Bystrica Slovakia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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