BDG -JIA: (1,3)-Béta-D-Glucan Levels at Diagnosis of Juvenile Idiopathic Arthritis and Its Correlation With Activity's Disease : a Cohort Sudy

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Unknown status
CT.gov ID
NCT03984669
Collaborator
(none)
40
1
11.7
3.4

Study Details

Study Description

Brief Summary

Juvenile idiopathic arthritis (JIA) is the most common pediatric rheumatic disease of childhood. Most children still experience prolonged periods of active disease, however, there is still lack of effective and specific markers for early diagnosis of relapse. The pathogenesis of JIA is thought to be the result of a combination of host genetic and environmental triggers and The microbiota is a potential contributing factor to the development of the disease. (1-3)-ß-D-Glucan (BDG), a component of most fungal cell walls, possess immunomodulatory activities. Latest studies demonstrate that it acts as a trigger for autoimmune arthritis in adult. However the relation with JIA is not clearly defined. The objective of this study was to evaluate the (1,3)-Béta-D-Glucans level in patients with JIA and whether higher serum BDG levels are correlated with JIA activity of disease, comparatively with usual markers.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: The Juvenile Disease Activity Score (JADAS)
  • Biological: (1-3)-ß-D-Glucan (BDG) assay (Fungitell)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
(1,3)-Béta-D-Glucan Levels at Diagnosis of Juvenile Idiopathic Arthritis and Its Correlation With Activity's Disease : a Cohort Sudy
Actual Study Start Date :
Jun 11, 2019
Anticipated Primary Completion Date :
Jun 1, 2020
Anticipated Study Completion Date :
Jun 1, 2020

Outcome Measures

Primary Outcome Measures

  1. Measure of (1,3)-Beta-D-Glucans level in patients with Juvenile Idiopathic Arthritis [one year]

    (1-3)-ß-D-Glucan (BDG), a component of most fungal cell walls, possess immunomodulatory activities. Latest studies demonstrate that it acts as a trigger for autoimmune arthritis in adult. BDG assays (Fungitell®) will be performed on serum of each JIA patients.

Secondary Outcome Measures

  1. Correlation of (1,3)-Beta-D-Glucans level in patients with Juvenile Idiopathic Arthritis score (JADAS) [one year]

    The JADAS includes the following four measures: physician's global assessment of disease activity, measured on a 0-10 visual analog scale (VAS) where 0 = no activity and 10 = maximum activity; parent global assessment of well-being, measured on a 0-10 VAS where 0 = very well and 10 = very poor; the erythrocyte sedimentation rate (ESR), normalized to a 0 to 10 scale; and a count of joints with active disease.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All patients under the age of 18 years with JIA's disease

  • followed at the CHU Amiens (French University hospital)

  • signed parent consent form

Exclusion Criteria:
  • lack of consent from parents or patient

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Amiens France 80054

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Djamal-Dine Djeddi, MD, CHU Amiens
  • Principal Investigator: Taieb Chouaki, MD, CHU Amiens

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT03984669
Other Study ID Numbers:
  • PI2018_843_0036
First Posted:
Jun 13, 2019
Last Update Posted:
Jun 13, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 13, 2019