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Evolution of Intestinal Microbiota in Patients With Juvenile Spondylarthropathy According to Typology of Treatment and Response to it (MESAJ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04540432
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : July 29, 2022
Sponsor:
Collaborators:
University Hospital, Montpellier
Assistance Publique Hopitaux De Marseille
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief 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.

Condition or disease Intervention/treatment Phase
Spondylarthropathies Other: Stool collection at the patient's home. Diagnostic Test: Blood test Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients will be split into 4 groups according to their treatment profile:

Profile A = patients on non-steroidal anti-inflammatory drugs.

Profile AM = patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate until the end of the study.

Profile AB = patients on non-steroidal anti-inflammatory drugs, followed by biotherapy until the end of the study.

Profile AMB = patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate and then biotherapy until the end of the study.

Profile M : methotrexate alone

Profile B : biothérapy alone

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Descriptive Study on the Evolution of Intestinal Microbiota Profiles in Patients With Juvenile Spondylarthropathy According to the Typology of Treatment and Response to it: A Descriptive, Prospective Pilot Study
Actual Study Start Date : September 22, 2021
Estimated Primary Completion Date : June 28, 2023
Estimated Study Completion Date : June 28, 2023


Arm Intervention/treatment
Experimental: Profile AB
Patients on non-steroidal anti-inflammatory drugs followed by biotherapy.
Other: Stool collection at the patient's home.
Stool samples will be taken from each patient to look for changes in intestinal microbiota. These collections will be made on Day 0 +24h, 24 hours before the 1st follow-up visit after 1 month of treatment with non-steroidal anti-inflammatory drugs, 24 hours after the second follow-up visit (between months 3 and 4) and finally, at the end of treatment.

Diagnostic Test: Blood test
7 ml of blood will be taken from each patient before treatment i.e. at the inclusion visit and at the end of treatment.

Experimental: Profile AM
Patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate.
Other: Stool collection at the patient's home.
Stool samples will be taken from each patient to look for changes in intestinal microbiota. These collections will be made on Day 0 +24h, 24 hours before the 1st follow-up visit after 1 month of treatment with non-steroidal anti-inflammatory drugs, 24 hours after the second follow-up visit (between months 3 and 4) and finally, at the end of treatment.

Diagnostic Test: Blood test
7 ml of blood will be taken from each patient before treatment i.e. at the inclusion visit and at the end of treatment.

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.
Stool samples will be taken from each patient to look for changes in intestinal microbiota. These collections will be made on Day 0 +24h, 24 hours before the 1st follow-up visit after 1 month of treatment with non-steroidal anti-inflammatory drugs, 24 hours after the second follow-up visit (between months 3 and 4) and finally, at the end of treatment.

Diagnostic Test: Blood test
7 ml of blood will be taken from each patient before treatment i.e. at the inclusion visit and at the end of treatment.

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

Diagnostic Test: Blood test
7 ml of blood will be taken from each patient before treatment i.e. at the inclusion visit and at the end of treatment.

Experimental: Profile M
methotrexate alone
Other: Stool collection at the patient's home.
Stool samples will be taken from each patient to look for changes in intestinal microbiota. These collections will be made on Day 0 +24h, 24 hours before the 1st follow-up visit after 1 month of treatment with non-steroidal anti-inflammatory drugs, 24 hours after the second follow-up visit (between months 3 and 4) and finally, at the end of treatment.

Diagnostic Test: Blood test
7 ml of blood will be taken from each patient before treatment i.e. at the inclusion visit and at the end of treatment.

Experimental: Profile B
biotherapy alone
Other: Stool collection at the patient's home.
Stool samples will be taken from each patient to look for changes in intestinal microbiota. These collections will be made on Day 0 +24h, 24 hours before the 1st follow-up visit after 1 month of treatment with non-steroidal anti-inflammatory drugs, 24 hours after the second follow-up visit (between months 3 and 4) and finally, at the end of treatment.

Diagnostic Test: Blood test
7 ml of blood will be taken from each patient before treatment i.e. at the inclusion visit and at the end of treatment.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged over 8 and under 16 years old.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04540432


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

Locations
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France
Nîmes University Hospital Recruiting
Nîmes, Gard, France, 30029
Contact: Anissa MEGZARI    +33 4 66 68 42 36    drc@chu-nimes.fr   
Principal Investigator: Tu-Anh TRAN, Prof.         
Sub-Investigator: Anne FILLERON, Dr.         
Sub-Investigator: Renaud CEZAR, Hospital engineer         
Sub-Investigator: Catherine DUNYACH-REMY, Dr.         
Sub-Investigator: Jean-Philippe LAVIGNE, Prof.         
Montpellier University Hospital, Arnaud de Villeneuve Hospital Recruiting
Montpellier, Hérault, France, 34295
Contact: Eric JEZIORSKI, Dr.    +33 4 67 33 22 86    e-jeziorski@chu-montpellier.fr   
Principal Investigator: Eric JEZIORSKI, Dr.         
Sub-Investigator: Aurelia CARBASSE, Dr.         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
University Hospital, Montpellier
Assistance Publique Hopitaux De Marseille
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04540432    
Other Study ID Numbers: NIMAO/2019/TAT-01
20.03.20.564 ( Other Identifier: CNRIPH )
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Microbiota
Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases