BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)

Copenhagen University Hospital, Hvidovre

Status: Enrolling

Conditions: Alcoholic Hepatitis

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05618418

H-21041462

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

30 participants in 1 patient group

Hospital admitted patients with alcoholic hepatitis

Description:

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 thrombosis Pregnancy Expected survival for less than one year caused by other diseases (based on decision from project responsible doctors)

Treatment:

Other: No intervention