NCT03092427

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

September 4, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2022

Completed
Last Updated

December 7, 2021

Status Verified

December 1, 2021

Enrollment Period

4 years

First QC Date

March 21, 2017

Last Update Submit

December 6, 2021

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

Primary 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 clinical activity

    American College of Rheumatology Pédiatrique score (ACR Pedi )

    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.

    3 months

Study Arms (2)

Probiotic VSL#3

EXPERIMENTAL
Dietary Supplement: VSL#3

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

VSL#3DIETARY_SUPPLEMENT

Dietary Supplement

Probiotic VSL#3
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Change of JIA forme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Debre Hospital

Paris, 75019, France

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ulrich Meinzer, MD/PhD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2017

First Posted

March 27, 2017

Study Start

September 4, 2017

Primary Completion

September 4, 2021

Study Completion

September 4, 2022

Last Updated

December 7, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)