BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)

Alcoholic Hepatitis Clinical Trial

— BATTLE  

Official title:

BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05618418
• Other study ID #: H-21041462
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: January 1, 2026

Study information

• Verified date: November 2022
• Source: Copenhagen University Hospital, Hvidovre
• Contact: frederik cold, MD, PHD
• Phone: +4521157167
• Email: frederik.cold[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcoholic Hepatitis
• Hepatitis, Alcoholic
• Liver Diseases

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Hvidovre	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Copenhagen University Hospital, Hvidovre	Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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