Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04540432

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

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
Phase
N/A
Study type
Interventional
Enrollment
25 (estimated)
Sponsor
Centre Hospitalier Universitaire de Nīmes · Academic / Other
Sex
All
Age
6 Years – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERStool 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_TESTBlood test7 ml of blood will be taken from each patient before treatment i.e. at the inclusion visit and at the end of treatment.

Timeline

Start date
2021-09-22
Primary completion
2029-06-28
Completion
2029-06-28
First posted
2020-09-07
Last updated
2025-11-17

Locations

4 sites across 1 country: France

Source: ClinicalTrials.gov record NCT04540432. Inclusion in this directory is not an endorsement.