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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
APHM, Hopital Nord
RECRUITING
Marseille
Montpellier University Hospital, Arnaud de Villeneuve Hospital
RECRUITING
Montpellier
Nîmes University Hospital
RECRUITING
Nîmes
Hopital des enfants, CHU de Toulouse
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Tu-Anh TRAN, Professor
tu.anh.tran@chu-nimes.fr
+33 4 66 32 86
Backup
Jean-Philippe LAVIGNE, Professor
jean.philippe.lavigne@chu-nimes.fr
+334 66 68 32 02
Time Frame
Start Date: 2021-09-22
Estimated Completion Date: 2029-06-28
Participants
Target number of participants: 25
Treatments
Experimental: Profile AB
Patients on non-steroidal anti-inflammatory drugs followed by biotherapy.
Experimental: Profile AM
Patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate.
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.
Experimental: Profile A
Patients on non-steroidal anti-inflammatory drugs.
Experimental: Profile M
methotrexate alone
Experimental: Profile B
biotherapy alone
Sponsors
Leads: Centre Hospitalier Universitaire de Nīmes
Collaborators: University Hospital, Montpellier, Assistance Publique Hopitaux De Marseille

This content was sourced from clinicaltrials.gov