Alcoholic HepatitisBATTLENCT05618418
BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)
An observational study of Alcoholic Hepatitis, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholic Hepatitis
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2022to 1 Jan 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital admitted patients with alcoholic hepatitis
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital Hvidovre
Hvidovre, 2650
frederik cold, MD, PHD, 21157167, frederik.cold@regionh.dk
About this study
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.
Read the 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.
- Conditions
- Alcoholic Hepatitis
- Being tested
- No intervention
- Keywords
- Gut microbiome
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (3)
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)
Measured: 1 year
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)
Measured: 30 days
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)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start1 Jul 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev
- Responsible party
- Principal investigator, Frederik Cold, Copenhagen University Hospital, Hvidovre
- Investigators
- frederik cold, MD, PHD, Principal investigator, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618418
- Sponsor's protocol ID
- H-21041462
- Acronym
- BATTLE
- Status last verified
- Nov 2022
- First submitted
- 3 Nov 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make data available to researchers
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)
- ClinicalTrials.gov ID
- NCT05618418
- Acronym / sponsor ID
- BATTLE / H-21041462
- Conditions
- Alcoholic Hepatitis
- Keywords
- Gut microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospital admitted patients with alcoholic hepatitis | – | Other: No interventionInclusion 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital admitted patients with alcoholic hepatitis
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- Hepatocellulary carcinoma
- Viral hepatitis
- Autoimmune hepatitis
- Portal vein thrombosis
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Hospital admitted patients with alcoholic hepatitis |
Primary outcome
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)
3 secondary outcomes
Survival in patients with and without cytolysin producing E. faecalis in fecal samples
Time frame: 1 year
Survival in patients with and without cytolysin producing E. faecalis in fecal samples
Time frame: 30 days
Survival in patients with and without cytolysin producing E. faecalis in fecal samples
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Individual participant dataSharing planned: No. No plan to make data available to researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
frederik cold, MD, PHD principal investigator
Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholic Hepatitis, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact frederik cold, MD, PHD (+4521157167, frederik.cold@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival in patients with and without cytolysin producing E. faecalis in fecal samples (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.