Probiotic Treatment in Juvenile Idiopathic Arthritis (JIA) (PERMAJI)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Juvenile Idiopathic Arthritis

Treatments: Other: Placebo; Dietary Supplement: VSL#3

Study type: Interventional

Funder types: Other

Identifiers

NCT03092427

P150934

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 1 to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups, including a placebo group

Probiotic VSL#3

Experimental group

Treatment:

Dietary Supplement: VSL#3

Placebo

Placebo Comparator group

Treatment:

Other: Placebo