Fecal Microbial Transplantation in Severe Alcoholic Hepatitis
NCT ID: NCT04758806
Last Updated: 2022-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
50 participants
INTERVENTIONAL
2018-04-01
2022-12-30
Brief Summary
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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.
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Detailed Description
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* Modified version of the Sarin FMT protocol is used with microbiota material procured from unrelated healthy donors.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Fecal microbial transplantation
Procured faeces procured from unrelated donor
Interventions
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Fecal microbial transplantation
Procured faeces procured from unrelated donor
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
OTHER
Responsible Party
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Ľubomír Skladaný MD, PhD
Head, Department of Internal Medicine and HEGITO Liver Unit, Principal Investigator
Principal Investigators
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Lubomir Skladany, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Head Dept Internal Medicine F.D.Roosevelt Teaching Hospital Banska Bystrica Slovakia
Locations
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F.D.Roosevelt Teaching Hospital
Banská Bystrica, , Slovakia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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432/2018-IK
Identifier Type: -
Identifier Source: org_study_id
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