PERMAJI: Probiotic Treatment in Juvenile Idiopathic Arthritis (JIA)

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03092427

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Actual Enrollment :

51 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 :

Sep 4, 2017

Actual Primary Completion Date :

Sep 4, 2021

Anticipated Study Completion Date :

Sep 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Probiotic VSL#3	Dietary Supplement: VSL#3 Dietary Supplement
Placebo Comparator: Placebo	Other: Placebo Placebo

Arm

Intervention/Treatment

Experimental: Probiotic VSL#3

Dietary Supplement: VSL#3

Dietary Supplement

Placebo Comparator: Placebo

Other: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Robert Debre Hospital	Paris		France	75019

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Ulrich Meinzer, MD/PhD, APHP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT03092427

Other Study ID Numbers:

P150934

First Posted:

Mar 27, 2017

Last Update Posted:

Dec 7, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Arthritis, Juvenile

Study Results

No Results Posted as of Dec 7, 2021