BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)

Study Overview
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Brief Summary
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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
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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.

Official Title
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BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)

Conditions
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Alcoholic Hepatitis

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospital admitted patients with alcoholic hepatitis<br>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) | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival in patients with and without cytolysin producing E. faecalis in fecal samples | Patient alive/not alive - Cytolysin producing E. faecalis in fecal samples from hospital admission (yes/no) | 1 year | 
| Survival in patients with and without cytolysin producing E. faecalis in fecal samples | Patient alive/not alive - Cytolysin producing E. faecalis in fecal samples from hospital admission (yes/no) | 30 days | 
| Survival in patients with and without cytolysin producing E. faecalis in fecal samples | Patient alive/not alive - Cytolysin producing E. faecalis in fecal samples from hospital admission (yes/no) | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut microbiome