Clinical Trials Logo
  1. Home
  2. Alcoholic Hepatitis
  3. NCT05618418
  4. Details
NCT05618418 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Recruiting NCT04066179 - Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients. N/A
Completed NCT03732586 - Effect of Omega 5 Fatty Acid as an Adyuvant Treatment to Prednisone in Patients With Severe Alcoholic Hepatitis N/A
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT00962442 - N-Acetylcysteine in Severe Acute Alcoholic Hepatitis Phase 3
Not yet recruiting NCT06307522 - MRG-001 in Patients With Alcoholic Hepatitis Phase 2
Recruiting NCT05018481 - HA35 Moderate Alcoholic Hepatitis (AH) Study Early Phase 1
Completed NCT04544020 - Changes in gUt micRobiota After Enteral Feeding (in Alcoholic Hepatitis)
Recruiting NCT04088370 - Peripheral Blood Mononuclear Cells Response In Healthy Controls, Heavy Drinkers, and Patients With Alcoholic Hepatitis
Completed NCT04235855 - EUS Guided Liver Biopsy - Will it Give Better Yield, More Tissue With Less Complication? N/A
Active, not recruiting NCT02344680 - Liver Fibrosis in Zambian HIV-HBV Co-infected Patients
Completed NCT00851981 - Randomized, Controlled Trial of S-adenosylmethionine in Alcoholic Liver Disease Phase 2
Completed NCT04084522 - Effect of Saturated Fat (Desi Ghee) on Gut-Liver Axis in Alcoholic Hepatitis N/A
Completed NCT05840640 - Granulocyte Colony Stimulating Factor Four Week Plus N-Acetyl Cysteine in Severe Alcoholic Hepatitis Phase 4
Recruiting NCT03069300 - N-ACetylcysteine to Reduce Infection and Mortality for Alcoholic Hepatitis Phase 3
Terminated NCT02039219 - Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH) Phase 2
Completed NCT01245257 - Effects of Prednisolone and Pentoxifylline on the Regulation of Urea Synthesis in Alcoholic Hepatitis N/A
Completed NCT02019056 - Efficacy and Safety of MG in the Patients With Alcoholic Fatty Liver Disease and Alcoholic Hepatitis Phase 2
Completed NCT00388323 - Adipose Tissue Involvement in Alcohol-induced Liver Inflammation in Human N/A
Recruiting NCT03845205 - Alcohol Treatment Outcomes Following Early vs. Standard Liver Transplant for SAH N/A
Recruiting NCT03703674 - GCSF in Alcoholic Hepatitis Phase 4