Evolution of Intestinal Microbiota in Patients With Juvenile Spondylarthropathy According to Typology of Treatment
NCT ID: NCT04540432
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2021-09-22
2029-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
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
TREATMENT
NONE
Study Groups
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Profile AB
Patients on non-steroidal anti-inflammatory drugs followed by biotherapy.
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.
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.
Profile AM
Patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate.
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.
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.
Profile AMB
Patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate and then biotherapy if there is no improvement with methotrexate.
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.
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.
Profile A
Patients on non-steroidal anti-inflammatory drugs.
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.
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.
Profile M
methotrexate alone
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.
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.
Profile B
biotherapy alone
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 who are within an exclusion period determined by another study.
6 Years
18 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Assistance Publique Hopitaux De Marseille
OTHER
Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Locations
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Nîmes University Hospital
Nîmes, Gard, France
Montpellier University Hospital, Arnaud de Villeneuve Hospital
Montpellier, Hérault, France
APHM, Hopital Nord
Marseille, , France
Hopital des enfants, CHU de Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Anne-Laure JURQUET
Role: primary
Other Identifiers
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NIMAO/2019/TAT-01
Identifier Type: -
Identifier Source: org_study_id
20.03.20.564
Identifier Type: OTHER
Identifier Source: secondary_id
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