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Fecal Microbial Transplantation in Severe Alcoholic Hepatitis (FMTH7)

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ClinicalTrials.gov Identifier: NCT04758806
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Ľubomír Skladaný MD, PhD, F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Alcoholic Hepatitis Biological: Fecal microbial transplantation Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Eligible for the study are consecutive consenting adult patients
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbial Transplantation for Corticosteroids Non-responders and Non-eligible Patients With Severe Alcoholic Hepatitis
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
Procured faeces procured from unrelated donor


Outcome Measures
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Primary Outcome Measures :
  1. Mortality [ Time Frame: 28-day ]
    Overall mortality

  2. Mortality [ Time Frame: 90-day ]
    Overall mortality

  3. Mortality [ Time Frame: 1 year ]
    Overall mortality


Secondary Outcome Measures :
  1. Acute on chronic liver failure [ Time Frame: In-Hospital ]
    Acute on chronic liver failure by European definition


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758806


Contacts
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Contact: Lubomir Skladany, MD,PhD +421905482997 lubomir.skladany@gmail.com
Contact: Natalia Bystrianska, MD +421917944393 naty2121@centrum.sk

Locations
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Slovakia
F.D.Roosevelt Teaching Hospital Recruiting
Banska Bystrica, Slovakia, 97401
Contact: Lubomir Skladany, MD, PhD    +421905482997    lubomir.skladany@gmail.com   
Contact: Natalia Bystrianska, MD    +421917944393    naty2121@centrum.sk   
Sub-Investigator: Daniela Jancekova, MD         
Sub-Investigator: Janka Vnencakova, MD         
Sponsors and Collaborators
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Investigators
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Principal Investigator: Lubomir Skladany, MD, PhD Head Dept Internal Medicine F.D.Roosevelt Teaching Hospital Banska Bystrica Slovakia
More Information
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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
ClinicalTrials.gov Identifier: NCT04758806    
Other Study ID Numbers: 432/2018-IK
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: On request by institution of interest, e.g. on submission to medical journal / by editorial office; by auditing authority
Supporting Materials: 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ľubomír Skladaný MD, PhD, F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica:
Alcoholic hepatitis
Nonresponders
fecal microbial transplantation
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders