Scientists probe immune cell damage in heavy drinkers
NCT ID NCT04088370
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares immune cell function in 30 healthy volunteers, heavy drinkers, and people with alcoholic hepatitis. Researchers will analyze blood samples to measure how mitochondria (the cell's powerhouses) work and how cells respond to inflammation. The goal is to better understand why some heavy drinkers develop severe liver disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could reveal how alcohol damages immune cells, pointing toward new targets for treating alcoholic hepatitis.
- What could go wrong
- This is a small, early observational study (30 participants) that only measures biological markers, not treatments. Results may not lead to direct therapies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2019
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with alcoholic hepatitis as diagnosed by liver biopsy, imaging, or biochemical values with noted encounter in Cleveland Clinic Electronic Medical Record, Heavy Drinking Controls - patients who lack any evidence (biochemical, imaging, and/or biopsy) of alcoholic liver disease who consume \>40 g/day or \>280g/week on average for women and \>60 g/day or \>420 g/week on average for men for a minimum of 6 months Healthy Controls - patients without any form of liver disease nd do not meet the criteria for "Heavy Drinking Controls"
- Ages
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21 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion of Subjects with Alcoholic Hepatitis (AH): \*diagnosis of AH either by imaging, biochemical values or liver biopsy as well as drinking history Inclusion Heavy Drinking Controls: \*heavy alcohol drinking will be defined as \>40 g/day or \>280g/week on average for women and \>60 g/day or \>420 g/week on average for men for a minimum of 6 months \[6\] and within the 4 weeks prior to study enrollment. Exclusion Criteria for all groups * inability or unwillingness to sign informed consent * cancer * autoimmune disease that in the opinion of the PI will confound study data Control subjects (drinking and non drinking) must meet the following criteria: * INR \< 1.4 * total bilirubin levels must \<3 * no prior history of known alcoholic liver disease * absence of hepatosplenomegaly (from physical examination or radiographic imaging) or stigmata of liver disease.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cleveland Clinic Foundation
RECRUITINGCleveland, Ohio, 44195, United States
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