RecruitingNAINTERVENTIONAL

Evolution of Intestinal Microbiota in Patients With Juvenile Spondylarthropathy According to Typology of Treatment

This study is exploring how treatments for a specific type of arthritis in children, called juvenile spondyloarthritis (JSpA), might affect the 'bugs' (microbiota) living in their gut. JSpA is a condition where children experience arthritis, sometimes with pain where tendons and ligaments attach to bones. Doctors use different medicines to treat it. We know that in adults, the gut bugs can sometimes change how well a medicine called methotrexate works. Since children with JSpA often have an imbalance in their gut bugs, this study wants to find out if certain arthritis medicines also change these bugs in young patients, and if that impacts how effective the treatment is. The goal is to better understand how these treatments work and help children feel better.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrolment target

Start

22 Sep 2021

Estimated completion

28 Jun 2029

Spondylarthropathies

What is this study about?

This research is looking into a condition called juvenile spondyloarthritis (JSpA). This is a type of arthritis that affects children and young people, often causing pain and swelling in their joints. It can also cause discomfort where certain tissues, like tendons, connect to bones.

Doctors use different medications to help manage JSpA. Some of these are anti-inflammatory drugs, and if those aren't enough, they might use stronger medicines called DMARDs, which stands for Disease-Modifying Anti-Rheumatic Drugs. One common DMARD is methotrexate. We know that the tiny living organisms, like bacteria, that live in our gut – often called our 'gut bugs' or microbiota – play a big role in our overall health.

Interestingly, in adults with similar conditions, research has shown that the gut bugs can sometimes affect how well a medicine like methotrexate works. We also know that children with JSpA often have a less balanced mix of gut bugs than healthy children. So, this study wants to explore whether the medicines given to children with JSpA change their gut bugs, and if these changes might then affect how well the treatment helps them feel better. By understanding this better, doctors hope to find ways to make treatments more effective for these young patients.

Key takeaways

Looks at how arthritis treatments affect gut health in children.
Focuses on juvenile spondyloarthritis (JSpA).
Involves stool samples and a blood test.
No new medication given, only observation of existing treatment.
Aims to improve future arthritis treatment for children.

Who may be eligible?

To be considered for this study, children need to be between 6 and 17 years old. They must have a specific diagnosis of juvenile enthesitis-related arthritis, which is a type of JSpA.

They also need to meet certain conditions regarding their current medications. Specifically, they shouldn't have taken methotrexate or stronger 'biotherapy' drugs for at least three months before joining the study, and they shouldn't have taken cortisone medication for at least one month. Finally, their parents or legal guardians must agree in writing for them to take part, and they need to be covered by either the Social Security System or private health insurance.

Children cannot join this study if they are already taking part in another clinical study that is considered 'category 1,' or if they have participated in such a study within the last three months. Also, if another study prevents them from joining new research for a certain period, they won't be able to participate.

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.

Is your child between 6 and 17 years old?
Does your child have a diagnosis of juvenile enthesitis-related arthritis?
Has your child NOT taken methotrexate or stronger 'biotherapy' drugs in the last 3 months?
Has your child NOT taken cortisone medication in the last month?
Are you (the parent/guardian) able to give written consent?
Is your child covered by UK Social Security or private health insurance?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will need to provide samples. This involves collecting stool (poo) samples at home, which will then be sent to the study team. They will also need to have a blood test. The study is mainly focused on collecting these samples and observing how their treatment for arthritis progresses. The researchers will be looking at how the 'gut bugs' change as a result of their usual treatment. There are no new or experimental medications given as part of this study; your child will continue with their prescribed arthritis treatment as normal. The total duration of participation isn't specified, but it would involve these sample collections over a period determined by the study.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that it helps doctors understand more about how arthritis treatments affect children's gut health and how effective their medication is. This could lead to better ways to treat juvenile spondyloarthritis in the future. The risks involved are generally low, mainly related to the minor discomfort of a blood test and the practicalities of collecting stool samples at home. You and your child are free to withdraw from the study at any time, for any reason, without it affecting your child's medical care.

Locations (4)

Nîmes University Hospital
Verified postcode
Nîmes, France· Recruiting
Montpellier University Hospital, Arnaud de Villeneuve Hospital
Verified postcode
Montpellier, France· Recruiting
APHM, Hopital Nord
Verified postcode
Marseille, France· Recruiting
Hopital des enfants, CHU de Toulouse
Verified postcode
Toulouse, France· Not yet recruiting

Common questions

What is juvenile spondyloarthritis (JSpA)?

JSpA is a type of arthritis that affects children and teenagers, causing joint pain, swelling, and sometimes pain where tissues like tendons attach to bones.

What are 'gut bugs' or microbiota?

These are the trillions of tiny living organisms, like bacteria and fungi, that live in our digestive system and play a role in our health.

Will my child receive new medicine in this study?

No, your child will continue with their regular arthritis treatment. This study observes the effects of those existing treatments.

What do I need to do if my child participates?

Your child will need to provide stool samples from home and have a blood test. Their parents or guardians will also need to give written permission.

Can we leave the study at any time?

Yes, you are free to withdraw your child from the study at any point without it affecting their medical care.

How to find out more

Tu-Anh TRAN, Professor

tu.anh.tran@chu-nimes.fr +33 4 66 32 86 Official trial record

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