Clinical trial NCT04540432: Evolution of Intestinal Microbiota in Patients With Juvenile Spondylarthropathy According to Typology of 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spondylarthropathies
Keywords: Microbiota
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: University Hospital, Montpellier
name: Assistance Publique Hopitaux De Marseille
First posted: 2020-09-07
Enrollment: 25
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Patients aged over 8 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.

Primary outcomes:
measure: 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.
timeFrame: 24 hours after inclusion
measure: 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.
timeFrame: 24 hours after inclusion
measure: 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.
timeFrame: 24 hours after inclusion
measure: 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.
timeFrame: After 1 month of treatment
measure: 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.
timeFrame: After 1 month of treatment
measure: 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.
timeFrame: After 1 month of treatment
measure: Response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A)
timeFrame: After 1 month of treatment
measure: Response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of flare-ups.
timeFrame: After 1 month of treatment
measure: 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.
timeFrame: 24 hours after inclusion
measure: 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.
timeFrame: 24 hours after inclusion
measure: 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.
timeFrame: 24 hours after inclusion
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM).Number of species.
timeFrame: After 1 month of treatment
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Distribution of species.
timeFrame: After 1 month of treatment
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Diversity of species.
timeFrame: After 1 month of treatment
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Number of species.
timeFrame: After 6 months of treatment
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Distribution of species.
timeFrame: After 6 months of treatment
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Diversity of species.
timeFrame: After 6 months of treatment
measure: Response to treatment in patients treated with non-steroidal anti-inflammatory drugs for 1 month followed by methotrexate for 5 months (Profile AM)
timeFrame: After 6 months of treatment
measure: 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.
timeFrame: After 6 months of treatment
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of species.
timeFrame: 24 hours after inclusion
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Distribution of species.
timeFrame: 24 hours after inclusion
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Diversity of species.
timeFrame: 24 hours after inclusion
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of species.
timeFrame: After 1 month of treatment
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Distribution of species.
timeFrame: After 1 month of treatment
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Diversity of species.
timeFrame: After 1 month of treatment
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of species.
timeFrame: After 6 months of treatment
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Distribution of species.
timeFrame: After 6 months of treatment
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Diversity of species.
timeFrame: After 6 months of treatment
measure: Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB)
timeFrame: After 6 months of treatment
measure: Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of flare-ups.
timeFrame: After 6 months of treatment
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of species.
timeFrame: 24 hours after inclusion
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Distribution of species.
timeFrame: 24 hours after inclusion
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Diversity of species.
timeFrame: 24 hours after inclusion
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of species.
timeFrame: After 1 month of treatment
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Distribution of species.
timeFrame: After 1 month of treatment
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Diversity of species.
timeFrame: After 1 month of treatment
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of species.
timeFrame: After 6 months of treatment
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Distribution of species.
timeFrame: After 6 months of treatment
measure: Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Diversity of species.
timeFrame: After 6 months of treatment
measure: Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB)
timeFrame: After 6 months of treatment
measure: Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of flare-ups.
timeFrame: After 6 months of treatment
Secondary outcomes:
measure: 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.
timeFrame: 24 hours after inclusion
measure: 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.
timeFrame: After 1 month of treatment
measure: 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.
timeFrame: 24 hours after inclusion
measure: 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.
timeFrame: After 6 months of treatment
measure: 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.
timeFrame: 24 hours after inclusion
measure: 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.
timeFrame: After 6 months of treatment
measure: 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.
timeFrame: 24 hours after inclusion
measure: 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.
timeFrame: After 6 months of treatment
measure: B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A)
timeFrame: 24 hours after inclusion
measure: B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A)
timeFrame: After 1 month of treatment
measure: B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM)
timeFrame: 24 hours after inclusion
measure: B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM)
timeFrame: After 6 months of treatment
measure: B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB)
timeFrame: 24 hours after inclusion
measure: B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB)
timeFrame: After 6 months of treatment
measure: 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)
timeFrame: 24 hours after inclusion
measure: 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)
timeFrame: After 6 months of treatment
measure: C:Constitution of a biobank of samples from Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
timeFrame: After 6 months of treatment
measure: C: Constitution of a biobank for Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate).
timeFrame: After 6 months of treatment
measure: C: Constitution of a biobank for Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
timeFrame: At the inclusion visit on Day 0
measure: C: Constitution of a biobank for AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
timeFrame: At the inclusion visit on Day 0
measure: Age of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
timeFrame: At the inclusion visit on Day 0
measure: Weight of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
timeFrame: At the inclusion visit on Day 0
measure: Height of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
timeFrame: At the inclusion visit on Day 0
measure: Sex of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
timeFrame: At the inclusion visit on Day 0
measure: Previous treatment in Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
timeFrame: At the inclusion visit on Day 0
measure: Dietary habits in Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
timeFrame: At the inclusion visit on Day 0
measure: Food allergies in Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
timeFrame: At the inclusion visit on Day 0
measure: Lifestyle of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
timeFrame: At the inclusion visit on Day 0
measure: Age of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
timeFrame: At the inclusion visit on Day 0
measure: Weight of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
timeFrame: At the inclusion visit on Day 0
measure: Height of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
timeFrame: At the inclusion visit on Day 0
measure: Sex of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
timeFrame: At the inclusion visit on Day 0
measure: Previous treatment in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
timeFrame: At the inclusion visit on Day 0
measure: Dietary habits in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
timeFrame: At the inclusion visit on Day 0
measure: Food allergies in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
timeFrame: At the inclusion visit on Day 0
measure: Lifestyle in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
timeFrame: At the inclusion visit on Day 0
measure: Age of Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
timeFrame: At the inclusion visit on Day 0
measure: Weight of Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
timeFrame: At the inclusion visit on Day 0
measure: Height of Profile AB patients (treated with non-steroidal anti-inflammatory drugs for then biotherapy)
timeFrame: At the inclusion visit on Day 0
measure: Sex of Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
timeFrame: At the inclusion visit on Day 0
measure: Previous treatment in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
timeFrame: At the inclusion visit on Day 0
measure: Dietary habits in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
timeFrame: At the inclusion visit on Day 0
measure: Food allergies in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
timeFrame: At the inclusion visit on Day 0
measure: Lifestyle in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
timeFrame: At the inclusion visit on Day 0
measure: Age of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate biotherapy)
timeFrame: At the inclusion visit on Day 0
measure: Weight of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
timeFrame: At the inclusion visit on Day 0
measure: Height of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
timeFrame: At the inclusion visit on Day 0
measure: Sex of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
timeFrame: At the inclusion visit on Day 0
measure: Previous treatment in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
timeFrame: At the inclusion visit on Day 0
measure: Dietary habits in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
timeFrame: At the inclusion visit on Day 0
measure: Food allergies in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
timeFrame: At the inclusion visit on Day 0
measure: Lifestyle in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
timeFrame: At the inclusion visit on Day 0
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Nîmes University Hospital
state: Gard
city: Montpellier
country: France
facility: Montpellier University Hospital, Arnaud de Villeneuve Hospital
state: Hérault
city: Marseille
country: France
facility: APHM, Hopital Nord
Study officials:
References: