RecruitingNAINTERVENTIONAL

Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease

This study is looking into how the body's inflammatory response and ability to heal itself might differ in people whose livers have been damaged by alcohol. We want to understand what makes these conditions worse or better. Researchers will compare three groups: people with sudden, severe alcoholic hepatitis, people with long-term alcoholic cirrhosis, and a control group of people whose livers are generally healthy. By examining blood samples and small pieces of liver tissue from these groups, the study hopes to find clues about the role of inflammation and repair processes in alcoholic liver diseases. This knowledge could eventually help in developing better treatments.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Lille

Enrolment target

450

Start

25 Dec 2014

Estimated completion

01 Sep 2027

Liver Diseases Acute on Chronic Hepatic Failure

What is this study about?

This research study is trying to understand more about how liver diseases caused by alcohol affect the body. Specifically, it's looking at inflammation (the body's response to injury or infection) and the liver's ability to heal itself. The liver is an amazing organ that can often repair itself, but with severe alcohol damage, this process can go wrong.

The study aims to compare three groups of people to get a complete picture. The first group has 'acute alcoholic hepatitis', which means a sudden and severe inflammation of the liver due to heavy drinking. The second group has 'alcoholic cirrhosis', which is a more long-term, serious scarring of the liver also caused by alcohol. The third group consists of people with generally healthy livers, who will act as a comparison.

By comparing these groups, researchers hope to identify differences in how their bodies react to inflammation and how their livers try to repair themselves. This information could be really important for understanding why some people develop more severe liver problems and could eventually lead to new ways to diagnose or treat these conditions more effectively.

Key takeaways

This study investigates alcoholic liver disease.
It compares inflammation and liver repair in different groups.
No new treatments or medicines are given.
Participation involves providing blood and possibly liver samples.
The goal is to improve future understanding and treatment.
Adults aged 18-70 with specific liver conditions or healthy livers may be eligible.

Who may be eligible?

This study is looking for adults aged 18 to 70. There are specific criteria to be included in one of the three groups being studied.

For the group with acute alcoholic hepatitis, you would need to have specific signs of recent heavy drinking and severe liver inflammation, along with very specific blood test results. A liver biopsy (a tiny sample of liver tissue) would be needed to confirm the diagnosis. For the group with alcoholic cirrhosis, you would need to have a diagnosis of cirrhosis caused by alcohol, which could be from a liver biopsy or other medical evidence.

People with healthy livers are also needed for comparison. This group would involve those who are having a blood or liver sample taken for another medical reason, for example, if they are having surgery for something else and their liver is healthy. There are also reasons why someone might not be able to join, such as having certain other liver diseases (like hepatitis B or C), HIV, other types of cancer, or being pregnant.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Do you have a diagnosis of severe alcoholic hepatitis?
Do you have a diagnosis of alcoholic cirrhosis?
Are you having a blood test or liver sample for another reason, and have generally healthy liver?
Are you free from other serious liver diseases like hepatitis B or C, or HIV?
Are you not currently pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't be given any new medications or treatments. The main part of your participation will involve providing samples that doctors would likely collect as part of your standard medical care anyway. This includes providing blood samples and, if needed for your diagnosis, a small piece of liver tissue (a liver biopsy). These samples will then be used by the research team to analyse your inflammatory profile (meaning the levels of certain chemicals your body produces when inflamed) and to look at your liver's ability to repair itself. Your participation would align with the medical care you would already be receiving for your liver condition, and there's no set duration for your involvement beyond the collection of these samples.

Potential risks and benefits

Taking part in this study does not involve new medical procedures beyond what might be required for your standard diagnosis and care. Therefore, the risks associated with providing blood samples or a liver biopsy are generally those that come with routine medical procedures. These are usually small, like bruising or discomfort at the site where blood is drawn, or, for a biopsy, a small risk of bleeding or infection. There isn't a direct personal benefit like a new treatment. However, your contribution is incredibly valuable as it will help doctors and scientists understand alcoholic liver disease better. This knowledge could lead to improved diagnosis and treatment for others in the future. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Hôpital Claude Huriez, CHRU
Verified postcode
Lille, France· Recruiting

Common questions

What is 'acute alcoholic hepatitis'?

It's a sudden, severe inflammation of the liver caused by heavy alcohol consumption, which can be very serious.

What is 'alcoholic cirrhosis'?

This is a long-term, serious scarring of the liver that happens after years of heavy alcohol use, leading to permanent damage.

Will I receive any new medicine in this study?

No, this study is observational, meaning it collects information from samples. You will not be given new medications as part of this research.

What is a liver biopsy?

A liver biopsy is a procedure where a tiny piece of your liver tissue is taken, usually with a thin needle, for examination under a microscope.

Who is the 'healthy liver' group?

This group consists of people who are having a blood or liver sample taken for another medical reason, but whose liver is generally healthy and not affected by chronic liver disease.

How to find out more

Philippe Mathurin, MD,PhD

philippe.mathurin@chru-lille.fr 03 20 44 55 97 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.