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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.
• Диагностический тест 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.

Первичные конечные точки

• 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. [Срок оценки: 24 hours after inclusion]
• 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. [Срок оценки: 24 hours after inclusion]
• 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. [Срок оценки: 24 hours after inclusion]
• 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. [Срок оценки: After 1 month of treatment]
• 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. [Срок оценки: After 1 month of treatment]
• 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. [Срок оценки: After 1 month of treatment]
• Response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) [Срок оценки: After 1 month of treatment]
• Response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of flare-ups. [Срок оценки: After 1 month of treatment]
• 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. [Срок оценки: 24 hours after inclusion]
• 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. [Срок оценки: 24 hours after inclusion]

Вторичные конечные точки (12)

• 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. [Срок оценки: 24 hours after inclusion]
• 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. [Срок оценки: After 1 month of treatment]
• 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. [Срок оценки: 24 hours after inclusion]
• 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. [Срок оценки: After 6 months of treatment]
• 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. [Срок оценки: 24 hours after inclusion]
• 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. [Срок оценки: After 6 months of treatment]
• 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. [Срок оценки: 24 hours after inclusion]
• 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. [Срок оценки: After 6 months of treatment]
• B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) [Срок оценки: 24 hours after inclusion]
• B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) [Срок оценки: After 1 month of treatment]
• B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM) [Срок оценки: 24 hours after inclusion]
• B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM) [Срок оценки: After 6 months of treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 4 центра

• Nîmes University Hospital — Nîmes
• Montpellier University Hospital, Arnaud de Villeneuve Hospital — Montpellier
• APHM, Hopital Nord — Marseille
• Hopital des enfants, CHU de Toulouse — Toulouse

Идентификаторы

NCT: NCT04540432 · NIMAO/2019/TAT-01 · 20.03.20.564

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗