Alcoholic HepatitisPhase 3FMTH7NCT04758806
Fecal Microbial Transplantation in Severe Alcoholic Hepatitis
A Phase 3 study testing Fecal microbial transplantation in people with Alcoholic Hepatitis, run by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica at 1 site in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Alcoholic Hepatitis
- What is being tested?
- Fecal microbial transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Apr 2018to 30 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Slovakia1 site, 1 recruiting
- Recruiting
F.D.Roosevelt Teaching Hospital
Banská Bystrica, 97401
Lubomir Skladany, MD, PhD, +421905482997, lubomir.skladany@gmail.com
Natalia Bystrianska, MD, +421917944393, naty2121@centrum.sk
About this study
Official title: Fecal Microbial Transplantation for Corticosteroids Non-responders and Non-eligible Patients With Severe Alcoholic Hepatitis
- 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.
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.
- Conditions
- Alcoholic Hepatitis
- Being tested
- Fecal microbial transplantation
- Keywords
- Alcoholic hepatitis, Nonresponders, fecal microbial transplantation
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbial transplantationBiological
Procured faeces procured from unrelated donor
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Fecal microbial transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Overall mortality
Measured: 28-day
Mortality
Overall mortality
Measured: 90-day
Mortality
Overall mortality
Measured: 1 year
Secondary outcomes (1)
Acute on chronic liver failure
Acute on chronic liver failure by European definition
Measured: In-Hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Apr 2018
- Primary completion30 Dec 2021
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Eligible for the study are consecutive consenting adult patients
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ľubomír Skladaný MD, PhD, F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
- Investigators
- Lubomir Skladany, MD, PhD, Principal investigator, Head Dept Internal Medicine F.D.Roosevelt Teaching Hospital Banska Bystrica Slovakia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758806
- Sponsor's protocol ID
- 432/2018-IK
- Acronym
- FMTH7
- Status last verified
- Aug 2022
- First submitted
- 21 Jan 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On request by institution of interest, e.g. on submission to medical journal / by editorial office; by auditing authority
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbial Transplantation for Corticosteroids Non-responders and Non-eligible Patients With Severe Alcoholic Hepatitis
- ClinicalTrials.gov ID
- NCT04758806
- Acronym / sponsor ID
- FMTH7 / 432/2018-IK
- Conditions
- Alcoholic Hepatitis
- Keywords
- Alcoholic hepatitis, Nonresponders, fecal microbial transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- F.D. Roosevelt Teaching Hospital with Policlinic Banska BystricaUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Eligible for the study are consecutive consenting adult patients
| Arm | Type | Receives |
|---|---|---|
| Fecal microbial transplantation from unrelated donor | Experimental | Biological: Fecal microbial transplantationFecal 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbial transplantationProcured faeces procured from unrelated donor | Biological | Fecal microbial transplantation from unrelated donor |
Primary outcome
Mortality
Time frame: 28-day
Overall mortality
Mortality
Time frame: 90-day
Overall mortality
Mortality
Time frame: 1 year
Overall mortality
1 secondary outcome
Acute on chronic liver failure
Time frame: In-Hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: Yes. On request by institution of interest, e.g. on submission to medical journal / by editorial office; by auditing authority
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lubomir Skladany, MD, PhD principal investigator
Head Dept Internal Medicine F.D.Roosevelt Teaching Hospital Banska Bystrica Slovakia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fecal microbial transplantation in people with Alcoholic Hepatitis, run by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lubomir Skladany, MD,PhD (+421905482997, lubomir.skladany@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 28-day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.