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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03092427
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis Dietary Supplement: VSL#3 Other: Placebo Not Applicable

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 4, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Probiotic VSL#3 Dietary Supplement: VSL#3
Dietary Supplement

Placebo Comparator: Placebo Other: Placebo
Placebo




Primary Outcome Measures :
  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 [ Time Frame: 3 months ]
    American College of Rheumatology Pédiatrique score (ACR Pedi )


Secondary Outcome Measures :
  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. [ Time Frame: 3 months ]
    Stool samples for intestinal microbiota analyses



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092427


Contacts
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Contact: Ulrich Meinzer, MD/PhD 33 1 40 03 20 48 ulrich.meinzer@aphp.fr
Contact: Albert Faye, MD/PhD 33 1 40 03 53 61 albert.faye@aphp.fr

Locations
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France
Robert Debre Hospital Recruiting
Paris, France, 75019
Contact: Ulrich Meinzer, MD    +33140032599    ulrich.meinzer@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Ulrich Meinzer, MD/PhD APHP
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03092427    
Other Study ID Numbers: P150934
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases