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

NCT03984669 — Not applicable, Completed, 40 participants, Centre Hospitalier Universitaire, Amiens

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Registry	NCT03984669, acronym BDG -JIA
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	40 (Actual)
Sponsor	Centre Hospitalier Universitaire, Amiens (Other)
Conditions	Juvenile Idiopathic Arthritis
Interventions	The Juvenile Disease Activity Score (JADAS), (1-3)-ß-D-Glucan (BDG) assay (Fungitell) (Diagnostic test, biological)
Dates	start 2019-06-11, primary completion 2020-06-01, completion 2020-06-01, first posted 2019-06-13, last updated 2023-01-18
Locations	1 site in France

-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.

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+Arms and interventions

The Juvenile Disease Activity Score (JADAS) (Diagnostic test): 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.
(1-3)-ß-D-Glucan (BDG) assay (Fungitell) (Biological): Evaluation of the (1,3)-Beta-D-Glucans level in patients with JIA and correlation of the higher serum BDG levels with JIA activity of disease, comparatively with usual markers

+Outcome measures

Primary outcomes

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 outcomes

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

Sex: All, ages: any to 18 Years

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

+Locations (1)

Facility	City	Country	Status
CHU Amiens	Amiens	France

+Investigators

Djamal-Dine Djeddi, MD, Principal investigator, CHU Amiens
Taieb Chouaki, MD, Principal investigator, CHU Amiens