Juvenile Idiopathic Arthritis
Conditions
Brief summary
This study investigates the efficacy of probiotic VSL#3 as an add on standard care on the activity of the disease in patients with Juvenile Idiopathic Arthritis.
Detailed description
Juvenile Idiopathic Arthritis (JIA) is the most frequent rheumatic disorder in children. Numerous studies suggest that alteration of the intestinal barrier may induce abnormal immune responses implicated in development or persistence of arthritis. This paves the way to new therapeutic options aiming to reestablish intestinal homeostasis to treat arthritis or to prevent disease flares. This study investigates the efficacy of probiotic VSL#3 as an add on standard care on the activity of the disease in patients with Juvenile Idiopathic Arthritis.
Interventions
DIETARY_SUPPLEMENTVSL#3
Dietary Supplement
OTHERPlacebo
Placebo
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥1year and \<7years * Patients with oligoarthritis and polyarthritis with rheumafactor negative and antinuclear antibodies (ANA) positive JIA with onset before the age of 6 years
Exclusion criteria
* Change of JIA forme
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the impact of a regular intake of probiotic VSL#3 in addition to standard treatment in patients with JIA on the clinical activity | 3 months | American College of Rheumatology Pédiatrique score (ACR Pedi ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the impact of a regular intake of probiotic VSL#3 in addition to standard treatment in patients with JIA on the intestinal microbiota. | 3 months | Stool samples for intestinal microbiota analyses |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORUlrich Meinzer, MD/PhD
APHP
Outcome results
None listed