BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)

Recruiting

• Conditions: Alcoholic Hepatitis
• Interventions: Other: No intervention

• Registration Number: NCT05618418
• Lead Sponsor: Copenhagen University Hospital, Hvidovre

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.

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2022-11
• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2022-11-10
• Last Update Submitted: 2022-11-10
• Study First Posted: 2022-11-16
• Last Update Posted: 2022-11-16
• Primary Completion: 2025-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hospital admitted patients with alcoholic hepatitis	No intervention	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Survival in patients with and without cytolysin producing E. faecalis in fecal samples	90 days	Patient alive/not alive - Cytolysin producing E. faecalis in fecal samples from hospital admission (yes/no)

Trial Locations

Locations (1)

Copenhagen University Hospital Hvidovre; 🇩🇰 Hvidovre, Denmark