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Fecal Microbial Transplantation in Severe Alcoholic Hepatitis

NCT04758806 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-08-03

No results posted yet for this 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.

Conditions

  • Alcoholic Hepatitis

Interventions

BIOLOGICAL

Fecal microbial transplantation

Procured faeces procured from unrelated donor

Sponsors & Collaborators

  • F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

    lead OTHER

Principal Investigators

  • Lubomir Skladany, MD, PhD · Head Dept Internal Medicine F.D.Roosevelt Teaching Hospital Banska Bystrica Slovakia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2021-12-30
Completion
2022-12-30

Countries

  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04758806 on ClinicalTrials.gov