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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stool collection at the patient's home.

    Other intervention

    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.

Treatment groups

25 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Profile ABExperimental treatment 2 interventions
Group B: Profile AMExperimental treatment 2 interventions
Group C: Profile AMBExperimental treatment 2 interventions
Group D: Profile AExperimental treatment 2 interventions
Group E: Profile MExperimental treatment 2 interventions
Group F: Profile BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of species detected in the intestinal microbiota.

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

Time frame
24 hours after inclusion
2

Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Distribution of species detected in the intestinal microbiota.

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

Time frame
24 hours after inclusion
3

Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Diversity of species detected in the intestinal microbiota.

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

Time frame
24 hours after inclusion
4

Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of species detected in the intestinal microbiota.

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

Time frame
After 1 month of treatment

Secondary outcomes

1

A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) and the clinical stage of evolution of Juvenile Spondylarthitis.

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

Time frame
24 hours after inclusion
2

A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) and the clinical stage of evolution of Juvenile Spondylarthitis.

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

Time frame
After 1 month of treatment
3

A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM) and the clinical stage of evolution of Juvenile Spondylarthitis.

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

Time frame
24 hours after inclusion
4

A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM) and the clinical stage of evolution of Juvenile Spondylarthitis.

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

Time frame
After 6 months of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Nīmes

Lead sponsor

University Hospital, Montpellier

Collaborator

Assistance Publique Hopitaux De Marseille

Collaborator