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Gut bacteria may hold key to why arthritis drugs stop working in kids

NCT ID NCT04540432

Knowledge-focused Sponsor: Centre Hospitalier Universitaire de Nīmes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is looking at how the gut bacteria (microbiome) change in children with juvenile spondyloarthritis as they receive different treatments. Researchers will collect stool and blood samples from 25 children over several months to see if certain bacteria affect how well the drugs work. The goal is to understand why some children stop responding to treatment, which could help doctors choose better therapies in the future.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors understand why some children stop responding to arthritis treatments, potentially leading to better personalized care.
What could go wrong
This is a very small, early pilot study with only 25 participants. It is designed to observe and describe, not to test a new treatment, so it may not lead to any direct changes in care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged over 6 and under 17 years old (included). * Patients diagnosed with arthritis with juvenile enthesitis according to the International League of Associations for Rheumatology (ILAR) criteria. * Patients who haven't been treated by Methotrexate or biotherapy for at least 3 months. * Patients who haven't been treated by cortisone for over a month. * Patients whose parents have given written informed consent. * Patients for whom the consent form has been signed by their legal guardian. * Patients covered by the Social Security System or benefitting from private health insurance. Exclusion Criteria: * Patients enrolled in another category 1 study or who have already taken part in a category 1 study within 3 months prior to inclusion. * Patients who are within an exclusion period determined by another study.

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Conditions

The condition(s) this trial relates to.

enthesitis-related juvenile idiopathic arthritis Spondylarthropathies spondyloarthropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spondylarthropathies

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHM, Hopital Nord

    RECRUITING

    Marseille, France

  • Hopital des enfants, CHU de Toulouse

    NOT_YET_RECRUITING

    Toulouse, France

  • Montpellier University Hospital, Arnaud de Villeneuve Hospital

    RECRUITING

    Montpellier, Hérault, 34295, France

  • Nîmes University Hospital

    RECRUITING

    Nîmes, Gard, 30029, France

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