Probiotic Treatment in Juvenile Idiopathic Arthritis (JIA)

Not Applicable

• Conditions: Juvenile Idiopathic Arthritis
• Interventions: Dietary Supplement: VSL#3; Other: Placebo

• Registration Number: NCT03092427
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-03-24
• Study First Posted: 2017-03-27
• Study Start: 2017-09-04
• Primary Completion: 2021-09-04
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-07
• Study Completion: 2022-09-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic VSL#3	VSL#3	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Robert Debre Hospital; 🇫🇷 Paris, France