RecruitingOBSERVATIONAL

INS, B Cells and Microbiota

This research is investigating a kidney condition called Idiopathic Nephrotic Syndrome (INS). We don't fully understand why some people get INS, but we know it can lead to serious kidney problems. The study is exploring connections between the 'good' and 'bad' bacteria in our gut, and certain immune cells in our blood, particularly B-lymphocytes and T-lymphocytes. Previous observations suggest that the immune system is involved in INS, and there might be links between allergies, diet, and flare-ups. Special treatments that target B cells have helped some patients, and problems with T cells have also been observed. This study aims to see if an imbalance in gut bacteria might affect these immune cells and trigger INS. By understanding this, we hope to find better ways to help people with this condition.

At a glance

Status

Recruiting

Sponsor

Nantes University Hospital

Enrolment target

Start

18 Jan 2022

Estimated completion

18 Jan 2027

Microbiota B-lymphocytes Glomerulosclerosis T-lymphocytes

What is this study about?

Idiopathic Nephrotic Syndrome (INS) is a kidney condition where your kidneys don't work as they should. This leads to your body losing important proteins in your urine, causing swelling and other problems. Unfortunately, we don't fully know what causes INS, and in some cases, it can lead to more serious, long-term kidney damage.

Over the years, doctors have noticed that the immune system, which usually fights off infections, seems to be involved. There have been hints that things like allergies and even diet might play a role in making the condition worse. We've also seen that treatments which target certain immune cells, called B cells, can help some patients. Similarly, other important immune cells, called T cells, also seem to be affected in people with INS.

More recently, researchers have started thinking about the connection between the bacteria in our gut – often called our 'gut microbiota' – and our immune system. This study is exploring the idea that an imbalance in these gut bacteria might affect immune cells like B cells and T cells, and in turn, trigger or worsen INS. By studying these connections, we hope to discover new ways to understand and treat this complex kidney condition.

Key takeaways

This study explores the link between gut bacteria and kidney disease.
It investigates how immune cells (B cells, T cells) might contribute to the condition.
The research aims to understand the unknown causes of Idiopathic Nephrotic Syndrome.
Participants will have blood and potentially stool samples taken for analysis.
This study does not involve new treatments, but rather observations.
Understanding these links could lead to future benefits for patients.

Who may be eligible?

This study is looking for people who are being treated at one of the participating hospitals. You would be considered if you are currently experiencing a 'nephrotic attack', which means you have high levels of protein in your urine. Your doctor can confirm if your protein levels meet the study’s requirements.

However, some people would not be able to join. This includes anyone who has had INS flare-ups that didn't respond to corticosteroid treatment, or if you are currently taking certain medications like immunosuppressants or high doses of corticosteroids (above 10mg per day).

The study also has restrictions based on weight and age. You would not be able to participate if you weigh less than 50 kg, are pregnant, or are under guardianship or curatorship. The study is open to both males and females, aged 12 years and older.

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.

Am I currently being treated at one of the hospitals involved in the study?
Do I have high protein levels in my urine (a 'nephrotic attack')?
Have I responded well to corticosteroid treatment for past flare-ups?
Am I currently taking immunosuppressant medications or high-dose corticosteroids?
Do I weigh at least 50 kg?
Am I pregnant?

Answer every question to see your result.

What does participation involve?

The specific details of what taking part involves are not fully described in the information provided. However, generally, studies like this that investigate immune populations and microbiota involve collecting blood samples to measure different types of immune cells and their activity. Stool samples might also be collected to analyse the types of bacteria living in your gut. You would likely have a few visits to the study hospital for these assessments. The study itself doesn't involve new medications, but rather observing your body's make-up. The total duration of your participation would depend on the study's plan for follow-up measurements, which is not specified here.

Potential risks and benefits

Participating in this study might help researchers better understand Idiopathic Nephrotic Syndrome, which could lead to better treatments for everyone in the future. As this study mainly involves measurements and not new treatments, the direct benefits to you might be limited. The main risks would likely be minor discomfort or bruising from blood draws. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (2)

Nantes University Hospital
Verified postcode
Nantes, France· Recruiting
Departemental Hospital Center
Verified postcode
La Roche-sur-Yon, France· Recruiting

Common questions

What is 'Idiopathic Nephrotic Syndrome'?

It's a kidney condition where your body loses too much protein in your urine. 'Idiopathic' means we don't know the exact cause yet.

What are 'B cells' and 'T cells'?

These are types of immune cells, like tiny soldiers in your body, that help fight off infections and keep you healthy. They are part of your immune system.

What does 'microbiota' mean?

It refers to all the tiny germs, like bacteria, that live in a particular part of your body, especially in your gut. They play an important role in your health.

Will I receive new treatment in this study?

No, this study is about taking measurements and observing. It's not testing a new medication or treatment.

How long will I be involved?

The information doesn't specify the exact duration, but research studies often involve several visits over a period of time to collect samples and information.

How to find out more

Christophe Masset

christophe.masset@chu-nantes.fr +33 2 76 64 39 61 Official trial record

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