Not yet recruitingNAINTERVENTIONAL

Innate Immunity, MIcrobiota and Inovative Treatments in Endometriosis

This study aims to better understand endometriosis, a condition affecting many women. Researchers believe that the body's immune system (its natural defences) and the bacteria in our gut (microbiota) might play an important role, but we don't fully understand how yet. The study will compare women with endometriosis to women without it. They will collect blood, stool (poo) samples, and tissue during surgery to look closely at immune cells and gut bacteria. The goal is to find new markers or clues that could lead to more effective treatments than current options, which don't always work for everyone. This research could open doors to new therapies for managing pain and improving quality of life for those with endometriosis.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University Hospital, Grenoble

Enrolment target

Start

09 Sep 2025

Estimated completion

30 Sep 2027

Endometriosis Immunity Microbiota

What is this study about?

Endometriosis is a common condition where tissue similar to the lining of the womb grows outside of it. This can cause pain and other problems, seriously affecting a woman's daily life. Current treatments, like hormone therapy or surgery, don't always work for everyone, and the condition can often come back. Scientists still don't fully understand why endometriosis develops or why it affects some women more severely than others. This lack of understanding means there's a strong need to find new and better ways to help.

This study focuses on two main areas that researchers think might be very important: our body's natural defence system (called the immune system) and the bacteria that live in our gut (known as the microbiota). Some studies suggest that the immune system in women with endometriosis might not be working quite right, especially specific immune cells. Also, there might be differences in the balance of gut bacteria in women with endometriosis compared to those without it. By examining these areas closely, the study hopes to uncover new links and clues about how the condition starts and progresses.

The main goal of this research is to identify 'biomarkers' – these are like signposts in the body (such as specific immune cells or types of gut bacteria) that could tell us more about endometriosis. Finding these biomarkers could help doctors understand the disease better, predict how it might progress, and, most importantly, lead to the development of completely new treatments. The study aims to find ways to reduce inflammation and manage symptoms more effectively, offering hope for long-term relief.

Key takeaways

This study explores the link between endometriosis, the immune system, and gut bacteria.
It aims to find new 'biomarkers' to better understand and treat the condition.
Participation involves providing blood, stool, and surgical tissue samples.
Women with endometriosis will be followed for 12 months; controls participate on surgery day only.
Your involvement could help develop future treatments for endometriosis.
You can withdraw from the study at any point without affecting your care.

Who may be eligible?

This study is looking for women aged 18 to 42. You would need to be scheduled for surgery during a specific time in your menstrual cycle.

If you have endometriosis, you can participate if your doctor has recommended surgery for your condition, either because your symptoms haven't improved with other treatments or because of a risk to your organs. You also need to have stopped any hormone therapy at least one month before your surgery. If you only have cysts on your ovaries (called ovarian endometrioma), this study might not be suitable for you.

If you don't have endometriosis, you can join if you're having surgery for another common gynaecological reason, and doctors don't find any signs of endometriosis during your operation. There are some health conditions that would prevent you from joining, such as inflammatory bowel disease, other autoimmune conditions (like lupus or rheumatoid arthritis), or if you've recently taken antibiotics, had an infection, or are pregnant or breastfeeding. You shouldn't be taking certain strong medications that affect your immune system, or have had recent abdominal surgery.

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 a woman aged between 18 and 42?
Are you scheduled for gynaecological surgery?
If you have endometriosis, has your doctor recommended surgery for it?
If you have endometriosis, have you stopped hormone therapy at least one month ago?
Do you have inflammatory bowel disease or other autoimmune conditions?
Have you recently taken antibiotics or had a serious infection?

Answer every question to see your result.

What does participation involve?

If you join this study, your participation will depend on whether you have endometriosis or are in the control group. All participants will have some samples collected during surgery, including tissue from the affected areas (if you have endometriosis) or healthy tissue (if you're a control). Everyone will also have a blood test during a routine visit and provide a stool (poo) sample at the beginning of the study.

For those without endometriosis (the control group), involvement is limited to the day of your surgery. You'll provide the samples mentioned, and that's it. For women with endometriosis, your participation will last for 12 months. You'll have an initial health check when you start, and a second stool sample will be collected 12 months later. You'll also have a follow-up health check at the one-year mark. No specific medication is provided as part of the study; treatments will be decided by your doctors based on standard care.

Potential risks and benefits

Potential benefits of taking part include helping researchers better understand endometriosis, which could lead to improved treatments for others in the future. While there are no direct personal benefits for you in this study, your contribution is valuable to medical science. Risks are generally low and mostly involve the usual risks associated with surgery and blood tests, as well as the minor inconvenience of providing stool samples. Your privacy will be protected. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

CHUGA
Verified postcode
Grenoble, France

Common questions

What is the main goal of this study?

The main goal is to find new clues (called biomarkers) in the body that can help us understand endometriosis better and develop new treatments.

What kinds of samples will be collected?

Researchers will collect blood, stool (poo) samples, and tissue from surgery (from areas affected by endometriosis or healthy tissue from controls).

How long will I be in the study if I have endometriosis?

If you have endometriosis, your participation will last for 12 months, with an initial visit and a follow-up visit after one year.

Will I get new medication as part of the study?

No, this study does not provide new medication. Your doctors will continue your usual care and treatments.

Can I stop participating in the study at any time?

Yes, you can leave the study at any time without it affecting your medical care.

How to find out more

Alexandre Buisson, Doctor

abuisson2@chu-grenoble.fr +33679825389 Official trial record

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