Role of Regulatory B Cells in Behçet's Disease

Completed

• Conditions: Behcet Disease
• Interventions: Diagnostic Test: Flow-cytometric assay; Diagnostic Test: 2D Echocardiographic analysis; Diagnostic Test: Two-Dimensional speckle tracking echocardiography

• Registration Number: NCT04376411
• Lead Sponsor: Assiut University

Brief Summary

There are limited data about the role of regulatory B cells in Behcet Disease. In this study we aimed to identify the proportions of total B lymphocytes and their regulatory subset in different Behcet Disease phenotype and therapies concentrating on the cardiovascular system attempting to unravel their function in Behcet Disease.

Detailed Description

Behçet's disease is a chronic multi-organ vasculitis characterized by recurrent oral and genital aphthae, skin lesions, widespread thrombosis and aneurysmal formation, and serious involvement of the eyes and central nervous system.

The innate and adaptive immune cells integrate in the pathogenesis of Behçet's disease. Interestingly, the gene expression analysis of Behçet's disease patients and healthy controls revealed the modulation of a range of genes involved in biological processes in Behçet's disease such as inflammation, apoptosis, angiogenesis, blood coagulation, vascular damage, signalling pathways, and immune responses, particularly, in innate immune cells, Th17 cells and B cells. Yet, the regulatory role of B cells in Behçet's disease has not been thoroughly investigated. Therefore, the aim of the current study is to identify the proportions of total B lymphocytes and their regulatory subset in different Behçet's disease phenotypes and therapies attempting to unravel their function in Behcet Disease. The role of B cells and regulatory B cells in the cardiovascular system affection in Behcet Disease was studied in more details.

Study Timeline

• Study Start: 2018-12-15
• Primary Completion: 2019-03-30
• Study Completion: 2019-12-15
• Status Verified: 2020-05
• Study First Submitted: 2020-05-03
• Study First Submitted QC: 2020-05-05
• Last Update Submitted: 2020-05-05
• Study First Posted: 2020-05-06
• Last Update Posted: 2020-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Thirty five adult patients who fulfilled the diagnostic criteria of Behcet Disease, and 39 age and sex matched healthy subjects as control

Exclusion Criteria

• Patients younger than 18 years old and those who were affected by other rheumatic disease other than Behcet Disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with Behcet disease	2D Echocardiographic analysis	Flow-cytometric assay Detailed 2 Di mention Echocardiographic analysis Two-Dimensional speckle tracking echocardiography
Healthy control subjects	Flow-cytometric assay	Flow-cytometric assay
patients with Behcet disease	Flow-cytometric assay	Flow-cytometric assay Detailed 2 Di mention Echocardiographic analysis Two-Dimensional speckle tracking echocardiography
patients with Behcet disease	Two-Dimensional speckle tracking echocardiography	Flow-cytometric assay Detailed 2 Di mention Echocardiographic analysis Two-Dimensional speckle tracking echocardiography

Primary Outcome Measures

Name	Time	Method
percentage of B and B regulatory cells in different Behcet phenotype	1 day (done once)	correlation between the B and B regulatory cells with different presentations of Behcet disease especially the cardiovascular manifestations.

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt