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NCT03092427 Clinical Trial

Probiotic Treatment in Juvenile Idiopathic Arthritis (JIA)

Juvenile Idiopathic Arthritis Clinical Trial

— PERMAJI  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03092427
Other study ID # P150934
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 4, 2017
Est. completion date September 4, 2022

Study information
Verified date December 2021
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 51
Est. completion date September 4, 2022
Est. primary completion date September 4, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Year to 7 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• VSL#3
Dietary Supplement
Other:
• Placebo
Placebo

Locations
Country Name City State
France Robert Debre Hospital Paris

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 ) 3 months
Secondary 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 3 months
See also
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Completed NCT02524340 - Patient Centered Adaptive Treatment Strategies Using Bayesian Causal Inference
Recruiting NCT01434082 - Sleep Patterns in Children With and Without Juvenile Idiopathic Arthritis N/A
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Recruiting NCT04167488 - Assessment of Physical Activity Among Juvenile Idiopathic Arthritis Children Performed With Actigraphy N/A
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Completed NCT02824978 - Therapeutic Alliance is it Associated With Better Compliance Amongst Children With Juvenile Idiopathic Arthritis ?
Active, not recruiting NCT03841357 - Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA) Phase 3
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Completed NCT01455701 - A Study to Evaluate Pharmacokinetics and Safety of Tocilizumab (RoActemra/Actemra) in Participants Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA) Phase 1
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Not yet recruiting NCT01436019 - Study of Antibodies to Anti-TNF Agents in Juvenile Idiopathic Arthritis N/A
Recruiting NCT05609630 - Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis. Phase 3
Recruiting NCT05696340 - Access to Pediatric Rheumatology Centers for JIA Patients: Factors Associated With Time to Access Pediatric Rheumatology Centers
Recruiting NCT05545839 - Transition to Adulthood Through Coaching and Empowerment in Rheumatology N/A
Completed NCT05436301 - Turkish Validity and Reliability of Pain Catastrophizing Scale-Child (PCS-C)
Not yet recruiting NCT05467579 - Mandibular Advancement Clear Aligner Treatment in Juvenile Idiopathic Arthritis Subjects N/A