Role of Regulatory B Cells in Behçet's Disease

Behcet Disease Clinical Trial

Official title:

Possible Role of Regulatory B Cells in Behçet's Disease: Special Interest in Cardiovascular System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04376411
• Other study ID #: 17300388
• Status: Completed
• Start date: December 15, 2018
• Est. completion date: December 15, 2019

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 15, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behcet Disease
• Behcet Syndrome

Intervention

Diagnostic Test:
• Flow-cytometric assay
100 µl of blood sample was incubated for 20 minutes at 4 C in the dark. Following incubation, red blood cells lysis, washing and analysis a specific software.Forward and side scatter histogram was used to define the lymphocytes population.
• 2D Echocardiographic analysis
Trans thoracic echocardiographic examination was performed through (PHILIPS -33) echocardiography device with broadband S5-1 transducer
• Two-Dimensional speckle tracking echocardiography
Two-Dimensional speckle tracking echocardiography was performed on grey scale images of the left ventricle. For offline analysis digital storage software (Qlab 10.4) was used. The frame rate was adjusted to be 60-90 frame/second.

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

1- Kural-Seyahi E, Fresko I, Seyahi N, Ozyazgan Y, Mat C, Hamuryudan V, et al. The long-term mortality and morbidity of Behcet syndrome: a 2-decade outcome survey of 387 patients followed at a dedicated center. Medicine (Baltimore). 2003;82(1):60-76. 2- Kirino Y, Bertsias G, Ishigatsubo Y, Mizuki N, Tugal-Tutkun I, Seyahi E, et al. Genome-wide association analysis identifies new susceptibility loci for Behcet's disease and epistasis between HLA-B*51 and ERAP1. Nat Genet. 2013;45(2):202-7. 3- Yoon JY, Lee Y, Yu SL, Yoon HK, Park HY, Joung CI, et al. Aberrant expression of interleukin-10 and activation-induced cytidine deaminase in B cells from patients with Behcet's disease. Biomed Rep. 2017;7(6):520-6.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of B and B regulatory cells in different Behcet phenotype	correlation between the B and B regulatory cells with different presentations of Behcet disease especially the cardiovascular manifestations.	1 day (done once)