Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04540432

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nîmes University Hospital, Nîmes, Gard, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stool collection at the patient's home.

Other

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.

Blood test

Diagnostic 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 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.

    Time frame: 24 hours after inclusion

    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.

  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.

    Time frame: 24 hours after inclusion

    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.

  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.

    Time frame: 24 hours after inclusion

    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.

  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.

    Time frame: After 1 month of treatment

    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.
  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.

    Time frame: After 1 month of treatment

    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.

  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.

    Time frame: After 1 month of treatment

    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.

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

    Time frame: After 1 month of treatment

    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.
  8. 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

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

  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.

    Time frame: 24 hours after inclusion

    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.

  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.

    Time frame: 24 hours after inclusion

    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.

  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.

    Time frame: 24 hours after inclusion

    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.

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

    Time frame: After 1 month of treatment

    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.

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

    Time frame: After 1 month of treatment

    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.

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

    Time frame: After 1 month of treatment

    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.

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

    Time frame: After 6 months of treatment

    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.

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

    Time frame: After 6 months of treatment

    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.

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

    Time frame: After 6 months of treatment

    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.

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

    Time frame: After 6 months of treatment

    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.
  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.

    Time frame: After 6 months of treatment

    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.

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

    Time frame: 24 hours after inclusion

    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.

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

    Time frame: 24 hours after inclusion

    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.

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

    Time frame: 24 hours after inclusion

    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.

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

    Time frame: After 1 month of treatment

    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.

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

    Time frame: After 1 month of treatment

    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.

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

    Time frame: After 1 month of treatment

    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.

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

    Time frame: After 6 months of treatment

    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.

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

    Time frame: After 6 months of treatment

    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.

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

    Time frame: After 6 months of treatment

    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.

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

    Time frame: After 6 months of treatment

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

    Time frame: After 6 months of treatment

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

  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.

    Time frame: 24 hours after inclusion

    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.

  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.

    Time frame: 24 hours after inclusion

    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.

  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.

    Time frame: 24 hours after inclusion

    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.

  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.

    Time frame: After 1 month of treatment

    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.

  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.

    Time frame: After 1 month of treatment

    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.

  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.

    Time frame: After 1 month of treatment

    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.

  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.

    Time frame: After 6 months of treatment

    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.

  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.

    Time frame: After 6 months of treatment

    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.

  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.

    Time frame: After 6 months of treatment

    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.

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

    Time frame: After 6 months of treatment

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

    Time frame: After 6 months of treatment

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

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.

    Time frame: 24 hours after inclusion

    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.

  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.

    Time frame: After 1 month of treatment

    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.

  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.

    Time frame: 24 hours after inclusion

    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.

  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.

    Time frame: After 6 months of treatment

    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.

  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.

    Time frame: 24 hours after inclusion

    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.

  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.

    Time frame: After 6 months of treatment

    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.

  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.

    Time frame: 24 hours after inclusion

    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.

  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.

    Time frame: After 6 months of treatment

    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.

  9. 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

    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).

  10. 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

    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).

  11. 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

    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).

  12. 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

    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).

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

    Time frame: 24 hours after inclusion

    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).

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

    Time frame: After 6 months of treatment

    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).

  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)

    Time frame: 24 hours after inclusion

    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).

  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)

    Time frame: After 6 months of treatment

    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).

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

    Time frame: After 6 months of treatment

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

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

    Time frame: After 6 months of treatment

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

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

    Time frame: At the inclusion visit on Day 0

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

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

    Time frame: At the inclusion visit on Day 0

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

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

    Time frame: At the inclusion visit on Day 0

    Recorded in years

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

    Time frame: At the inclusion visit on Day 0

    Recorded in kilos

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

    Time frame: At the inclusion visit on Day 0

    Recorded in cm.

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

    Time frame: At the inclusion visit on Day 0

    Male/Female

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

    Time frame: At the inclusion visit on Day 0

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

    Time frame: At the inclusion visit on Day 0

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

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

    Time frame: At the inclusion visit on Day 0

    The investigators will record details of patients' food allergies.

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

    Time frame: At the inclusion visit on Day 0

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

    Time frame: At the inclusion visit on Day 0

    Recorded in years

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

    Time frame: At the inclusion visit on Day 0

    Recorded in kilos

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

    Time frame: At the inclusion visit on Day 0

    Recorded in cm.

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

    Time frame: At the inclusion visit on Day 0

    Male/Female

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

    Time frame: At the inclusion visit on Day 0

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

    Time frame: At the inclusion visit on Day 0

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

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

    Time frame: At the inclusion visit on Day 0

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

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

    Time frame: At the inclusion visit on Day 0

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

    Time frame: At the inclusion visit on Day 0

    Recorded in years

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

    Time frame: At the inclusion visit on Day 0

    Recorded in kilos

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

    Time frame: At the inclusion visit on Day 0

    Recorded in cm.

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

    Time frame: At the inclusion visit on Day 0

    Male/Female

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

    Time frame: At the inclusion visit on Day 0

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

    Time frame: At the inclusion visit on Day 0

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

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

    Time frame: At the inclusion visit on Day 0

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

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

    Time frame: At the inclusion visit on Day 0

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

    Time frame: At the inclusion visit on Day 0

    Recorded in years

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

    Time frame: At the inclusion visit on Day 0

    Recorded in kilos

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

    Time frame: At the inclusion visit on Day 0

    Recorded in cm.

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

    Time frame: At the inclusion visit on Day 0

    Male/Female

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

    Time frame: At the inclusion visit on Day 0

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

    Time frame: At the inclusion visit on Day 0

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

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

    Time frame: At the inclusion visit on Day 0

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

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

    Time frame: At the inclusion visit on Day 0

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Philippe LAVIGNE, Professor

CONTACT

[email protected]

+334 66 68 32 02

Tu-Anh TRAN, Professor

CONTACT

[email protected]

+33 4 66 32 86

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • Assistance Publique Hopitaux De Marseille
  • University Hospital, Montpellier

Registry information

Official study 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

Acronym: MESAJ

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Sep 7, 2020
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.