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Recruiting NCT04540432

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

No phase Interventional Spondylarthropathies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stool collection at the patient's home., Blood test.
Who it may be relevant to
Registry conditions: Spondylarthropathies. Basic parameters: 6 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Other Stool collection at the patient's home.
    Stool samples will be taken from each patient to look for changes in intestinal microbiota. These collections will be made on Day 0 +24h, 24 hours before the 1st follow-up visit after 1 month of treatment with non-steroidal anti-inflammatory drugs, 24 hours after the second follow-up visit (between months 3 and 4) and finally, at the end of treatment.
  • Diagnostic test Blood test
    7 ml of blood will be taken from each patient before treatment i.e. at the inclusion visit and at the end of treatment.

Primary outcome measures

  • Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of species detected in the intestinal microbiota. [Time frame: 24 hours after inclusion]
  • Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Distribution of species detected in the intestinal microbiota. [Time frame: 24 hours after inclusion]
  • Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Diversity of species detected in the intestinal microbiota. [Time frame: 24 hours after inclusion]
  • Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of species detected in the intestinal microbiota. [Time frame: After 1 month of treatment]
  • Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Distribution of species detected in the intestinal microbiota. [Time frame: After 1 month of treatment]
  • Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Diversity of species detected in the intestinal microbiota. [Time frame: After 1 month of treatment]
  • Response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) [Time frame: After 1 month of treatment]
  • Response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of flare-ups. [Time frame: After 1 month of treatment]
  • Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Number of species detected in the intestinal microbiota. [Time frame: 24 hours after inclusion]
  • Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Distribution of species detected in the intestinal microbiota. [Time frame: 24 hours after inclusion]
Secondary outcome measures (12)
  • A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) and the clinical stage of evolution of Juvenile Spondylarthitis. [Time frame: 24 hours after inclusion]
  • A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) and the clinical stage of evolution of Juvenile Spondylarthitis. [Time frame: After 1 month of treatment]
  • A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM) and the clinical stage of evolution of Juvenile Spondylarthitis. [Time frame: 24 hours after inclusion]
  • A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM) and the clinical stage of evolution of Juvenile Spondylarthitis. [Time frame: After 6 months of treatment]
  • A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB) and the clinical stage of evolution of Juvenile Spondylarthitis. [Time frame: 24 hours after inclusion]
  • A: Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB) and the clinical stage of evolution of Juvenile Spondylarthitis. [Time frame: After 6 months of treatment]
  • A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy (Profile AMB) and the clinical stage of evolution of Juvenile Spondylarthitis. [Time frame: 24 hours after inclusion]
  • A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy (Profile AMB) and the clinical stage of evolution of Juvenile Spondylarthitis. [Time frame: After 6 months of treatment]
  • B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) [Time frame: 24 hours after inclusion]
  • B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) [Time frame: After 1 month of treatment]
  • B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM) [Time frame: 24 hours after inclusion]
  • B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM) [Time frame: After 6 months of treatment]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 4 centers
  • Nîmes University Hospital — Nîmes
  • Montpellier University Hospital, Arnaud de Villeneuve Hospital — Montpellier
  • APHM, Hopital Nord — Marseille
  • Hopital des enfants, CHU de Toulouse — Toulouse

Identifiers

NCT: NCT04540432 · NIMAO/2019/TAT-01 · 20.03.20.564

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗