Juvenile Idiopathic ArthritisPERMAJINCT03092427
Probiotic Treatment in Juvenile Idiopathic Arthritis (JIA)
A study testing VSL#3 in people with Juvenile Idiopathic Arthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- VSL#3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2017to 4 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Change of JIA forme
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of a Probiotic Treatment on Clinical Activity, Relapse Rates and Modification of the Intestinal Microbiota in Patients With Juvenile Idiopathic Arthritis (JIA)
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.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- VSL#3, Placebo
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSL#3Dietary supplement
Dietary Supplement
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic VSL#3 | Experimental | Not described Receives: Dietary Supplement: VSL#3 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start4 Sep 2017
- Primary completion4 Sep 2021
- Study completion4 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrich Meinzer, MD/PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092427
- Sponsor's protocol ID
- P150934
- Acronym
- PERMAJI
- Status last verified
- Dec 2021
- First submitted
- 21 Mar 2017
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Probiotic Treatment on Clinical Activity, Relapse Rates and Modification of the Intestinal Microbiota in Patients With Juvenile Idiopathic Arthritis (JIA)
- ClinicalTrials.gov ID
- NCT03092427
- Acronym / sponsor ID
- PERMAJI / P150934
- Conditions
- Juvenile Idiopathic Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 4 Sep 2021 (actual)
- Study completion
- 4 Sep 2022 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic VSL#3 | Experimental | Dietary Supplement: VSL#3 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Change of JIA forme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VSL#3Dietary Supplement | Dietary supplement | Probiotic VSL#3 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
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
Time frame: 3 months
American College of Rheumatology Pédiatrique score (ACR Pedi )
1 secondary outcome
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.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Meinzer, MD/PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VSL#3 in people with Juvenile Idiopathic Arthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.