BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05618418

Acronym

BATTLE

Enrollment

Registered

2022-11-16

Start date

2022-07-01

Completion date

2026-01-01

Last updated

2022-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic Hepatitis

Keywords

Gut microbiome

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.

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.

Interventions

OTHERNo intervention

No intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 18 * Bilirubin \> 50 micromol/L * History of large alcoholic consumption in period prior to hospital admission (in the last six months) * No bile-duct obstruction (investigated through US, CT og MRI)

Exclusion criteria

* Hepatocellulary carcinoma * Viral hepatitis * Autoimmune hepatitis * Portal vein thrombosis * Pregnancy * Expected survival for less than one year caused by other diseases (based on decision from project responsible doctors

Design outcomes

Primary

Measure	Time frame	Description
Survival in patients with and without cytolysin producing E. faecalis in fecal samples	6 months	Patient alive/not alive - Cytolysin producing E. faecalis in fecal samples from hospital admission (yes/no)

Secondary

Measure	Time frame	Description
Survival in patients with and without cytolysin producing E. faecalis in fecal samples	1 year	Patient alive/not alive - Cytolysin producing E. faecalis in fecal samples from hospital admission (yes/no)

Countries

Denmark

Contacts

Primary Contactfrederik cold, MD, PHD

frederik.cold@regionh.dk+4521157167

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026