Using bacteria to understand survival in alcoholic hepatitis
BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)
This study is trying to see if certain bacteria in the gut can affect how well people with alcoholic hepatitis do over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Copenhagen University Hospital, Hvidovre Academic / other |
| Locations | 1 site (Hvidovre) |
| Trial ID | NCT05618418 on ClinicalTrials.gov |
What this trial studies
The BATTLE trial investigates the correlation between specific bacterial strains and survival rates in patients with alcoholic hepatitis. Patients admitted to Copenhagen University Hospital Hvidovre and Herlev will provide blood and fecal samples for analysis. Over a one-year follow-up period, the study will examine whether the presence of cytolysin-producing E. faecalis is linked to decreased survival chances. This observational study aims to identify potential microbial factors influencing patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of alcoholic hepatitis and elevated bilirubin levels.
Not a fit: Patients with conditions such as hepatocellular carcinoma, viral hepatitis, or those expected to survive less than one year due to other diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of the gut microbiome's role in alcoholic hepatitis and inform future treatment strategies.
How similar studies have performed: While studies on the gut microbiome's impact on various diseases are emerging, this specific approach to alcoholic hepatitis is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hvidovre
- Copenhagen University Hospital Hvidovre — Hvidovre, Denmark (Recruiting)
Study contacts
- Principal investigator: frederik cold, MD, PHD — Copenhagen University Hospital, Hvidovre
- Study coordinator: frederik cold, MD, PHD
- Email: frederik.cold@regionh.dk
- Phone: +4521157167
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.