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

November 10, 2022 updated by: Frederik Cold, Copenhagen University Hospital, Hvidovre

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Recruiting
        • Copenhagen University Hospital Hvidovre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hospital admitted patients with alcoholic hepatitis

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
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival in patients with and without cytolysin producing E. faecalis in fecal samples
Time Frame: 6 months
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
Time Frame: 1 year
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
Time Frame: 30 days
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
Time Frame: 90 days
Patient alive/not alive - Cytolysin producing E. faecalis in fecal samples from hospital admission (yes/no)
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital, Hvidovre

Collaborators

Copenhagen University Hospital at Herlev

Investigators

  • Principal Investigator: frederik cold, MD, PHD, Copenhagen University Hospital, Hvidovre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2026

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

November 10, 2022

First Posted (Actual)

November 16, 2022

Study Record Updates

Last Update Posted (Actual)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 10, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-21041462

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan to make data available to researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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