ClinicalTrials.gg
RecruitingNCT04540432MESAJUpdated Nov 17, 2025

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

An interventional study of Stool collection at the patient's home. and Blood test in Spondylarthropathies, sponsored by Centre Hospitalier Universitaire de Nīmes. Recruiting at 4 sites in France. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2021; still recruiting 5 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
6 Years to 18 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Spondylarthropathies

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Keywords

  • Microbiota
03

In context

Spondylarthropathies

68 studies on the registry are indexed under Spondylarthropathies; 10 are open to participants now.

This study's planned enrollment of 25 is below the median of 103 across 40 interventional studies indexed under Spondylarthropathies.

Browse Spondylarthropathies studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Profile AB

    Patients on non-steroidal anti-inflammatory drugs followed by biotherapy.

    Other: Stool collection at the patient's home. · Diagnostic Test: Blood test

  • Experimental
    Profile AM

    Patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate.

    Other: Stool collection at the patient's home. · Diagnostic Test: Blood test

  • Experimental
    Profile AMB

    Patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate and then biotherapy if there is no improvement with methotrexate.

    Other: Stool collection at the patient's home. · Diagnostic Test: Blood test

  • Experimental
    Profile A

    Patients on non-steroidal anti-inflammatory drugs.

    Other: Stool collection at the patient's home. · Diagnostic Test: Blood test

  • Experimental
    Profile M

    methotrexate alone

    Other: Stool collection at the patient's home. · Diagnostic Test: Blood test

  • Experimental
    Profile B

    biotherapy alone

    Other: Stool collection at the patient's home. · Diagnostic Test: Blood test

Interventions

  • OtherStool 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 testBlood 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded.

    Time frame: 24 hours after inclusion

  2. 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.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.

    Time frame: 24 hours after inclusion

  3. 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.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.

    Time frame: 24 hours after inclusion

  4. 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.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded. \- the diversity index according to the number of species and the number of functional groups.

    Time frame: After 1 month of treatment

  5. 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.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.

    Time frame: After 1 month of treatment

  6. 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.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The diversity index according to the number of species and the number of functional groups will be recorded.

    Time frame: After 1 month of treatment

  7. Response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A)

    The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures: * the physician's global assessment of disease activity; * the parent/guardian's or patient's global assessment of overall wellbeing; * number of joints with active arthritis; and * C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.

    Time frame: After 1 month of treatment

  8. Response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of flare-ups.

    The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) will be noted.

    Time frame: After 1 month of treatment

  9. 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.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded.

    Time frame: 24 hours after inclusion

  10. 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.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.

    Time frame: 24 hours after inclusion

  11. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Diversity of species detected in the intestinal microbiota.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The diversity index according to the number of species and the number of functional groups will be recorded.

    Time frame: 24 hours after inclusion

  12. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM).Number of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.

    Time frame: After 1 month of treatment

  13. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Distribution of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.

    Time frame: After 1 month of treatment

  14. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Diversity of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.

    Time frame: After 1 month of treatment

  15. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Number of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.

    Time frame: After 6 months of treatment

  16. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Distribution of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species in the microbiota will be recorded.

    Time frame: After 6 months of treatment

  17. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Diversity of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.

    Time frame: After 6 months of treatment

  18. Response to treatment in patients treated with non-steroidal anti-inflammatory drugs for 1 month followed by methotrexate for 5 months (Profile AM)

    The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures: * the physician's global assessment of disease activity; * the parent/guardian's or patient's global assessment of overall wellbeing; * number of joints with active arthritis; and * C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.

    Time frame: After 6 months of treatment

  19. Response to treatment in patients treated with non-steroidal anti-inflammatory drugs for 1 month followed by methotrexate for 5 months (Profile AM). Number of flare-ups.

    The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs for 1 month followed by methotrexate for 5 months (Profile AM) will be noted.

    Time frame: After 6 months of treatment

  20. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.

    Time frame: 24 hours after inclusion

  21. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Distribution of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species in the microbiota will be recorded.

    Time frame: 24 hours after inclusion

  22. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Diversity of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.

    Time frame: 24 hours after inclusion

  23. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.

    Time frame: After 1 month of treatment

  24. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Distribution of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.

    Time frame: After 1 month of treatment

  25. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Diversity of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.

    Time frame: After 1 month of treatment

  26. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.

    Time frame: After 6 months of treatment

  27. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Distribution of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.

    Time frame: After 6 months of treatment

  28. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Diversity of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.

    Time frame: After 6 months of treatment

  29. Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB)

    The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures: * the physician's global assessment of disease activity; * the parent/guardian's or patient's global assessment of overall wellbeing; * number of joints with active arthritis; and * C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.

    Time frame: After 6 months of treatment

  30. Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of flare-ups.

    The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB) will be noted.

    Time frame: After 6 months of treatment

  31. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded.

    Time frame: 24 hours after inclusion

  32. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Distribution of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.

    Time frame: 24 hours after inclusion

  33. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Diversity of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The diversity index according to the number of species and the number of functional groups will be recorded.

    Time frame: 24 hours after inclusion

  34. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.

    Time frame: After 1 month of treatment

  35. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Distribution of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.

    Time frame: After 1 month of treatment

  36. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Diversity of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.

    Time frame: After 1 month of treatment

  37. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.

    Time frame: After 6 months of treatment

  38. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Distribution of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.

    Time frame: After 6 months of treatment

  39. Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Diversity of species.

    Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.

    Time frame: After 6 months of treatment

  40. Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB)

    The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures: * the physician's global assessment of disease activity; * the parent/guardian's or patient's global assessment of overall wellbeing; * number of joints with active arthritis; and * C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.

    Time frame: After 6 months of treatment

  41. Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of flare-ups.

    The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB) will be noted.

    Time frame: After 6 months of treatment

Secondary outcomes

  1. 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.

    The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.

    Time frame: 24 hours after inclusion

  2. 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.

    The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.

    Time frame: After 1 month of treatment

  3. 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.

    The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.

    Time frame: 24 hours after inclusion

  4. 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.

    The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.

    Time frame: After 6 months of treatment

  5. 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.

    The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.

    Time frame: 24 hours after inclusion

  6. 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.

    The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.

    Time frame: After 6 months of treatment

  7. 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.

    The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.

    Time frame: 24 hours after inclusion

  8. 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.

    The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.

    Time frame: After 6 months of treatment

  9. B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A)

    Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).

    Time frame: 24 hours after inclusion

  10. B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A)

    Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).

    Time frame: After 1 month of treatment

  11. B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM)

    Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).

    Time frame: 24 hours after inclusion

  12. B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM)

    Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).

    Time frame: After 6 months of treatment

  13. B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB)

    Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).

    Time frame: 24 hours after inclusion

  14. B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB)

    Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).

    Time frame: After 6 months of treatment

  15. B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB)

    Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).

    Time frame: 24 hours after inclusion

  16. B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB)

    Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).

    Time frame: After 6 months of treatment

  17. C:Constitution of a biobank of samples from Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)

    All blood and stool samples used for the study will be deposited in the biobank for reference.

    Time frame: After 6 months of treatment

  18. C: Constitution of a biobank for Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate).

    All blood and stool samples used for the study will be deposited in the biobank for reference.

    Time frame: After 6 months of treatment

  19. C: Constitution of a biobank for Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)

    All blood and stool samples used for the study will be deposited in the biobank for reference.

    Time frame: At the inclusion visit on Day 0

  20. C: Constitution of a biobank for AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)

    All blood and stool samples used for the study will be deposited in the biobank for reference.

    Time frame: At the inclusion visit on Day 0

  21. Age of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)

    Recorded in years

    Time frame: At the inclusion visit on Day 0

  22. Weight of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)

    Recorded in kilos

    Time frame: At the inclusion visit on Day 0

  23. Height of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)

    Recorded in cm.

    Time frame: At the inclusion visit on Day 0

  24. Sex of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)

    Male/Female

    Time frame: At the inclusion visit on Day 0

  25. Previous treatment in Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)

    The investigators will record details of all treatment followed prior to diagnosis of juvenile spondylarthritis: * NSAIDs : dosage and dates * Corticoids : dosage and dates * Antibiotics : dosage and dates * DMARDs : dosage and dates

    Time frame: At the inclusion visit on Day 0

  26. Dietary habits in Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)

    The investigators will record details of patients' dietary habits and, more particularly, note all foods which are excluded.

    Time frame: At the inclusion visit on Day 0

  27. Food allergies in Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)

    The investigators will record details of patients' food allergies.

    Time frame: At the inclusion visit on Day 0

  28. Lifestyle of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)

    The investigators will record details of the patient's lifestyle: * Brothers and sisters (number and date of birth of each one) * Communities (date of entry) * Contact with animals

    Time frame: At the inclusion visit on Day 0

  29. Age of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)

    Recorded in years

    Time frame: At the inclusion visit on Day 0

  30. Weight of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)

    Recorded in kilos

    Time frame: At the inclusion visit on Day 0

  31. Height of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)

    Recorded in cm.

    Time frame: At the inclusion visit on Day 0

  32. Sex of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)

    Male/Female

    Time frame: At the inclusion visit on Day 0

  33. Previous treatment in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)

    The investigators will record details of all treatment followed prior to diagnosis of juvenile spondylarthritis: * NSAIDs : dosage and dates * Corticoids : dosage and dates * Antibiotics : dosage and dates * DMARDs : dosage and dates

    Time frame: At the inclusion visit on Day 0

  34. Dietary habits in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)

    The investigators will record details of all patients' dietary habits and, more particularly, note all foods which are excluded.

    Time frame: At the inclusion visit on Day 0

  35. Food allergies in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)

    The investigators will record details of all patients' food allergies.

    Time frame: At the inclusion visit on Day 0

  36. Lifestyle in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)

    The investigators will record details of the patient's lifestyle: * Brothers and sisters (number and date of birth of each one) * Communities (date of entry) * Contact with animals

    Time frame: At the inclusion visit on Day 0

  37. Age of Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)

    Recorded in years

    Time frame: At the inclusion visit on Day 0

  38. Weight of Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)

    Recorded in kilos

    Time frame: At the inclusion visit on Day 0

  39. Height of Profile AB patients (treated with non-steroidal anti-inflammatory drugs for then biotherapy)

    Recorded in cm.

    Time frame: At the inclusion visit on Day 0

  40. Sex of Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)

    Male/Female

    Time frame: At the inclusion visit on Day 0

  41. Previous treatment in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)

    The investigators will record details of all treatment followed prior to diagnosis of juvenile spondylarthritis: * NSAIDs : dosage and dates * Corticoids : dosage and dates * Antibiotics : dosage and dates * DMARDs : dosage and dates

    Time frame: At the inclusion visit on Day 0

  42. Dietary habits in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)

    The investigators will record details of all patients' dietary habits and, more particularly, note all foods which are excluded.

    Time frame: At the inclusion visit on Day 0

  43. Food allergies in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)

    The investigators will record details of all patients' food allergies.

    Time frame: At the inclusion visit on Day 0

  44. Lifestyle in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)

    The investigators will record details of the patient's lifestyle: * Brothers and sisters (number and date of birth of each one) * Communities (date of entry) * Contact with animals

    Time frame: At the inclusion visit on Day 0

  45. Age of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate biotherapy)

    Recorded in years

    Time frame: At the inclusion visit on Day 0

  46. Weight of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)

    Recorded in kilos

    Time frame: At the inclusion visit on Day 0

  47. Height of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)

    Recorded in cm.

    Time frame: At the inclusion visit on Day 0

  48. Sex of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)

    Male/Female

    Time frame: At the inclusion visit on Day 0

  49. Previous treatment in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)

    The investigators will record details of all treatment followed prior to diagnosis of juvenile spondylarthritis: * NSAIDs : dosage and dates * Corticoids : dosage and dates * Antibiotics : dosage and dates * DMARDs : dosage and dates

    Time frame: At the inclusion visit on Day 0

  50. Dietary habits in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)

    The investigators will record details of all patients' dietary habits and, more particularly, note all foods which are excluded.

    Time frame: At the inclusion visit on Day 0

  51. Food allergies in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)

    The investigators will record details of all patients' food allergies.

    Time frame: At the inclusion visit on Day 0

  52. Lifestyle in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)

    The investigators will record details of the patient's lifestyle: * Brothers and sisters (number and date of birth of each one) * Communities (date of entry) * Contact with animals

    Time frame: At the inclusion visit on Day 0

07

Study locations

3 of 4 sites recruiting
  • Nîmes University Hospital
    Nîmes, Gard 30029, France
    Recruiting
    • Anissa MEGZARI · Contactdrc@chu-nimes.fr · +33 4 66 68 42 36
    • Tu-Anh TRAN, Prof. · Principal investigator
    • Anne FILLERON, Dr. · Sub investigator
    • Renaud CEZAR, Hospital engineer · Sub investigator
    • Catherine DUNYACH-REMY, Dr. · Sub investigator
    • Jean-Philippe LAVIGNE, Prof. · Sub investigator
  • Montpellier University Hospital, Arnaud de Villeneuve Hospital
    Montpellier, Hérault 34295, France
    Recruiting
    • Eric JEZIORSKI, Dr. · Contacte-jeziorski@chu-montpellier.fr · +33 4 67 33 22 86
    • Eric JEZIORSKI, Dr. · Principal investigator
    • Aurelia CARBASSE, Dr. · Sub investigator
  • APHM, Hopital Nord
    Marseille, France
    Recruiting
    • Anne-Laure JURQUET · Contact
  • Hopital des enfants, CHU de Toulouse
    Toulouse, France
    Not yet recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2021 (actual). Primary completion is estimated for Jun 2029, 93 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2020
First posted
Sep 7, 2020
StartActual
Sep 22, 2021
Primary completionEst.
Jun 28, 2029
CompletionEst.
Jun 28, 2029
Last update
Nov 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04540432
Responsible party
Sponsor
First posted
Sep 7, 2020
Start date
Sep 22, 2021
Primary completion
Jun 28, 2029 (estimated)
Completion
Jun 28, 2029 (estimated)
Last update
Nov 17, 2025

Study contacts

Tu-Anh TRAN, Professor
Contact
tu.anh.tran@chu-nimes.fr
+33 4 66 32 86
Jean-Philippe LAVIGNE, Professor
Contact
jean.philippe.lavigne@chu-nimes.fr
+334 66 68 32 02

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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