- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03092427
Probiotic Treatment in Juvenile Idiopathic Arthritis (JIA) (PERMAJI)
December 6, 2021 updated by: Assistance Publique - Hôpitaux de Paris
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France, 75019
- Robert Debre Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 7 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo
|
Experimental: Probiotic VSL#3
|
Dietary Supplement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 )
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Stool samples for intestinal microbiota analyses
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ulrich Meinzer, MD/PhD, APHP
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 4, 2017
Primary Completion (Actual)
September 4, 2021
Study Completion (Anticipated)
September 4, 2022
Study Registration Dates
First Submitted
March 21, 2017
First Submitted That Met QC Criteria
March 24, 2017
First Posted (Actual)
March 27, 2017
Study Record Updates
Last Update Posted (Actual)
December 7, 2021
Last Update Submitted That Met QC Criteria
December 6, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P150934
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Juvenile Idiopathic Arthritis
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University of AarhusAarhus University HospitalCompletedPolyarticular Juvenile Rheumatoid Arthritis | Systemic Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis, OligoarthritisDenmark
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Institut National de la Santé Et de la Recherche...CompletedSystemic-Onset Juvenile Idiopathic ArthritisFrance
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GeneScience Pharmaceuticals Co., Ltd.Not yet recruitingActive Systemic Juvenile Idiopathic ArthritisChina
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Novartis PharmaceuticalsCompletedSystemic Juvenile Idiopathic Arthritis (SJIA)Italy, Russian Federation, Turkey, Belgium, Spain, Germany, France, Israel, Canada, United States, Hungary, Austria, Brazil, Sweden, Netherlands, Poland
-
Novartis PharmaceuticalsPediatric Rheumatology International Trials OrganizationCompletedSystemic Juvenile Idiopathic Arthritis With Active FlareUnited States, Argentina, Canada, Switzerland, Germany, Israel, South Africa, Belgium, Italy, Spain, France, Brazil, Turkey, Hungary, Poland, Norway, Sweden, Netherlands, Peru
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AbbVieCompletedPolyarticular Juvenile Idiopathic Arthritis
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AbbottCompletedArthritis, Juvenile IdiopathicUnited States, Belgium, Czech Republic, France, Germany, Italy, Slovakia, Spain
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Assistance Publique - Hôpitaux de ParisRecruitingJuvenile Idiopathic Arthritis (JIA)France
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