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CompletedNCT03092427PERMAJIUpdated Apr 6, 2026

Probiotic Treatment in Juvenile Idiopathic Arthritis (JIA)

An interventional study of VSL#3 and Placebo in Juvenile Idiopathic Arthritis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 1 Year to 7 Years. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
1 Year to 7 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Juvenile Idiopathic Arthritis

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03

In context

Arthritis, Juvenile

352 studies on the registry are indexed under Arthritis, Juvenile; 92 are open to participants now.

This study's enrollment of 51 is close to the median of 50 across 225 interventional studies indexed under Arthritis, Juvenile.

Browse Arthritis, Juvenile studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,506 studies on the registry; 1,007 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 7 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Change of JIA forme
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    Probiotic VSL#3

    Dietary Supplement: VSL#3

  • Placebo comparator
    Placebo

    Other: Placebo

Interventions

  • Dietary supplementVSL#3

    Dietary Supplement

  • OtherPlacebo

    Placebo

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What researchers measure

Primary outcomes

  1. 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

    American College of Rheumatology Pédiatrique score (ACR Pedi )

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Stool samples for intestinal microbiota analyses

    Time frame: 3 months

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Study locations

1 site
  • Robert Debre Hospital
    Paris, 75019, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03092427
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Mar 27, 2017
Start date
Sep 4, 2017
Primary completion
Sep 4, 2021
Completion
Sep 4, 2022
Last update
Apr 6, 2026

Study contacts

Ulrich Meinzer, MD/PhD
principal investigator · APHP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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