Exploring how treatment affects gut bacteria in young patients with spondylarthropathy
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
This study is trying to see how different treatments for juvenile spondylarthropathy affect gut bacteria in kids aged 8 to 17.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Drugs / interventions | Methotrexate |
| Locations | 4 sites (Nîmes, Gard and 3 other locations) |
| Trial ID | NCT04540432 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 8 to 17 diagnosed with juvenile spondylarthropathy who have not received specific treatments recently.
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.
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 performed: While the impact of microbiota on treatment response has been explored in adults, this specific approach in pediatric patients is relatively novel.
Eligibility criteria
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 this trial is running
Nîmes, Gard and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.