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

RecruitingNAAges 6 Years - 18 YearsAllCentre Hospitalier Universitaire de Nīmes
NCT04540432 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Idiopathic juvenile arthritis includes 20% of patients with arthritis with enthesitis or juvenile spondyloarthropathy. This is treated with anti-inflammatory drugs and then followed by biotherapy with DMARDs (Drugs Modifying the Activity of Rheumatic Disease) if the former are insufficient. Methotrexate (MTX) may also be used before these biotherapies. Recently, in adults, a particular profile of intestinal microbiota has been shown to alter the availability of MTX making it in efficient. Knowing that pediatric patients with juvenile spondyloarthropathy have an imbalance of their intestinal flora (dysbiosis) the investigators wanted to explore whether DMARDs could have a similar impact on the microbiota of these young patients and alter the response to treatment.

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📋 Eligibility rules (as published)
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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What it tests

  • Stool collection at the patient's home.
  • Blood test
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Where

4 sites
Nîmes University Hospital
Nîmes, France
Montpellier University Hospital, Arnaud de Villeneuve Hospital
Montpellier, France
APHM, Hopital Nord
Marseille, France
Hopital des enfants, CHU de Toulouse
Toulouse, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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