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BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)

Sponsor
Copenhagen University Hospital, Hvidovre (Other)
Overall Status
Recruiting
CT.gov ID
NCT05618418
Collaborator
Copenhagen University Hospital at Herlev (Other)
30
Enrollment
1
Location
42.1
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Survival in patients with and without cytolysin producing E. faecalis in fecal samples [1 year]

    Patient alive/not alive - Cytolysin producing E. faecalis in fecal samples from hospital admission (yes/no)

  2. Survival in patients with and without cytolysin producing E. faecalis in fecal samples [30 days]

    Patient alive/not alive - Cytolysin producing E. faecalis in fecal samples from hospital admission (yes/no)

  3. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Copenhagen University Hospital Hvidovre Hvidovre Denmark 2650

Sponsors and Collaborators

  • Copenhagen University Hospital, Hvidovre
  • Copenhagen University Hospital at Herlev

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Frederik Cold, Principal Investigator, MD, Ph.d., Specialist Registrar in Medical Gastroenterology, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier:
NCT05618418
Other Study ID Numbers:
  • H-21041462
First Posted:
Nov 16, 2022
Last Update Posted:
Nov 16, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Frederik Cold, Principal Investigator, MD, Ph.d., Specialist Registrar in Medical Gastroenterology, Copenhagen University Hospital, Hvidovre
Gut microbiome
Additional relevant MeSH terms:
Liver Diseases
Hepatitis, Alcoholic

Study Results

No Results Posted as of Nov 16, 2022