RecruitingOBSERVATIONAL

Pathogenic Study of Adult Immune Enteropathies

This research aims to understand why the immune system in the gut sometimes stops working properly. It focuses on conditions like coeliac disease (where the body reacts to gluten), autoimmune enteropathy, and inflammatory bowel diseases. Researchers are trying to discover how the gut's natural balance is disrupted in these illnesses. They will also investigate how immune cells in the gut can change and potentially lead to more serious conditions, such as certain types of lymphoma, which are cancers of the immune system. Additionally, the study will look at how similar immune imbalances might affect the liver in related diseases. This work helps us learn more about these complex conditions.

At a glance

Status

Recruiting

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Enrolment target

200

Start

27 Feb 2020

Estimated completion

27 Feb 2033

Celiac Disease Autoimmune Enteropathy Inflammatory Bowel Diseases

What is this study about?

This study is called 'Pathogenic Study of Adult Immune Enteropathies' and it's all about understanding certain conditions where the body's immune system affects the gut. Think of your gut as a complex neighbourhood with a delicate balance – sometimes, this balance gets upset, and your immune system, which usually protects you, starts causing problems.

Researchers are particularly interested in conditions like coeliac disease, where eating gluten causes an immune reaction in the small intestine. They're also looking at other similar conditions, including autoimmune enteropathy, various inflammatory bowel diseases (like Crohn's disease or ulcerative colitis), and even gut problems caused by medicines. The main goal is to figure out *why* this immune system imbalance happens and what goes wrong with the immune cells themselves. They want to understand how these immune cells might change over time, which could potentially lead to more serious health issues, such as a type of cancer called lymphoma.

Beyond the gut, the study will also explore if similar immune system problems affect the liver in related conditions. By gathering this information, scientists hope to gain a much clearer picture of these illnesses. This improved understanding is crucial because it can help doctors diagnose these conditions earlier, develop better treatments, and ultimately improve the lives of people living with these challenging gut and liver conditions.

Key takeaways

This study investigates why immune diseases affect the gut.
It aims to understand diseases like coeliac disease and inflammatory bowel diseases.
Participation involves providing blood and gut tissue samples.
Your contribution helps advance our understanding for future treatments.
You must be 18 or over and able to give consent to participate.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To join this study, you must be an adult aged 18 or over. You also need to be covered by social insurance, which is typical for most people in the UK. Importantly, you must be able to understand what the study involves and be able to give your clear permission (called 'informed consent') to take part.

There are some reasons why you wouldn't be able to join. For example, if you are pregnant, you won't be eligible. Also, if you are legally under the care of a guardian or are unable to properly understand and sign the consent forms yourself, you wouldn't be able to participate. This is to make sure everyone who takes part does so willingly and safely.

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 18 years old or older?
Are you covered by social insurance (e.g., NHS in the UK)?
Are you able to understand the study and willingly agree to take part?
Are you not pregnant?
Are you able to sign the consent form yourself?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would need to provide some samples. This includes giving a blood sample, which is a common procedure. You would also have a gastrointestinal biopsy, which involves taking a small tissue sample from your gut. This is usually done during an endoscopy procedure already needed for your clinical care. The study doesn't involve taking any new medications or specific follow-up visits beyond your usual medical appointments. The total duration of your active participation, mainly providing the samples, would be relatively short, but the researchers would then study these samples over a longer period.

Potential risks and benefits

Taking part in research always has a balance of potential benefits and risks. For this study, you might not directly benefit yourself, but your contribution will help doctors and scientists learn more about complex gut conditions, which could lead to better diagnoses and treatments for others in the future. The main risks involve the standard procedures of blood collection and gastrointestinal biopsy; these are generally safe but carry small risks like bruising from blood tests or minor discomfort from a biopsy. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Hôpital Henri Mondor
Verified postcode
Créteil, France· Not yet recruiting
Hôpital Bicêtre
Verified postcode
Le Kremlin-Bicêtre, France· Not yet recruiting
Hôpital Saint Louis
Verified postcode
Paris, France· Not yet recruiting
Hôpital Cochin
Verified postcode
Paris, France· Recruiting

Common questions

What exactly is an 'immune enteropathy'?

It's a medical term for conditions where your immune system mistakenly attacks your gut (intestines), causing inflammation and problems with how your gut works.

Why do you need blood and gut samples?

Researchers will study these samples to look at the immune cells and activity in your body, hoping to understand what goes wrong in these conditions.

Will taking part change my medical treatment?

No, this study focuses on understanding the disease mechanisms and won't change your current or future medical treatment plan.

Is this study looking for new treatments?

While this study won't test new treatments directly, the information gained could be vital for developing new and better therapies in the future.

Is my personal information kept private?

Yes, all your personal and medical information will be kept strictly confidential and anonymous, following strict privacy rules.

How to find out more

Georgia MALAMUT, MD, PhD

georgia.malamut@aphp.fr 33 1 58 41 41 76 Official trial record

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