Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05618418
Status:
RECRUITING
Last Update Posted:
2022-11-16
First Post:
2022-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)
Sponsor:
Copenhagen University Hospital, Hvidovre
Organization:
Study Overview
Official Title:
BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
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:
BATTLE
Brief Summary:
Alcoholic hepatitis is a disease with a high mortality rate with few treatment options improving survival. Recently certain bacterial strains has been correlated to survival in patients with alcoholic hepatitis.
In the BATTLE-trial the investigators will investigate if certain bacteria are correlated to decreased chance of survival in patients with alcoholic hepatitis.
In the BATTLE-trial the investigators will investigate if certain bacteria are correlated to decreased chance of survival in patients with alcoholic hepatitis.
Detailed Description:
Patients with alcoholic hepatitis who are admitted to Copenhagen University Hospital Hvidovre and Herlev will be invited to participate.
Blood and fecal samples following hospital admission will be collected. Through one-year follow-up correlation of certain bacteria in fecal samples with survival will be investigated.
In particular whether patients with cytolysin producing E. faecalis has a decreased chance of survival compared to patients without this bacteria.
Blood and fecal samples following hospital admission will be collected. Through one-year follow-up correlation of certain bacteria in fecal samples with survival will be investigated.
In particular whether patients with cytolysin producing E. faecalis has a decreased chance of survival compared to patients without this bacteria.
Study Oversight
Has Oversight DMC:
False
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?: