Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04758806
Status:
UNKNOWN
Last Update Posted:
2022-08-03
First Post:
2021-01-21
Brief Title:
Fecal Microbial Transplantation in Severe Alcoholic Hepatitis
Sponsor:
FD Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Organization:
FD Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Study Overview
Official Title:
Fecal Microbial Transplantation for Corticosteroids Non-responders and Non-eligible Patients With Severe Alcoholic Hepatitis
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FMTH7
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
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
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
Modified version of the Sarin FMT protocol is used with microbiota material procured from unrelated healthy donors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None