Exploring how treatment affects gut bacteria in young patients with spondylarthropathy
Official title: Descriptive Study on the Evolution of Intestinal Microbiota Profiles in Patients With Juvenile Spondylarthropathy According to the Typology of Treatment and Response to it: A Descriptive, Prospective Pilot Study
Run by Centre Hospitalier Universitaire de Nīmes · NCT04540432 · Data updated 2026-11-12
This study is trying to see how different treatments for juvenile spondylarthropathy affect gut bacteria in kids aged 8 to 17.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 18 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Drugs / interventions | Methotrexate |
| Locations | 4 sites (Nîmes, Gard and 3 other locations) |
| Status | Recruiting |
| Started | September 22, 2021 |
| Main results expected | June 28, 2029 |
| Study ends | June 28, 2029 |
| Registry record updated | November 17, 2025 |
| Trial ID | NCT04540432 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 8 to 17 diagnosed with juvenile spondylarthropathy who have not received specific treatments recently.
✕Probably not a fit
Patients currently enrolled in other clinical studies or those who have recently participated in similar studies may not benefit from this research.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the evolution of intestinal microbiota in pediatric patients diagnosed with juvenile spondylarthropathy who are receiving different types of treatments. It aims to understand how anti-inflammatory drugs and DMARDs influence gut bacteria and potentially affect treatment efficacy. The methodology includes stool collection at home and blood tests to analyze the microbiota and its relationship with treatment response. The study focuses on patients aged 8 to 17 who have not been treated with certain medications for a specified period.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for juvenile spondylarthropathy by considering the role of gut microbiota.
How similar studies have gone: While the impact of microbiota on treatment response has been explored in adults, this specific approach in pediatric patients is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Nîmes University Hospital
Nîmes, Gard, France Recruiting -
Montpellier University Hospital, Arnaud de Villeneuve Hospital
Montpellier, Hérault, France Recruiting -
APHM, Hopital Nord
Marseille, France Recruiting -
Hopital des enfants, CHU de Toulouse
Toulouse, France Not yet recruiting
Study contacts
- Study coordinator: Tu-Anh TRAN, Professor
- Email: tu.anh.tran@chu-nimes.fr
- Phone: +33 4 66 32 86
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.