Differential EBI2 Expression Upon Allelic Status of the rs9557195 Polymorphism

• Conditions: Inflammatory Bowel Diseases

• Registration Number: NCT03633409
• Lead Sponsor: University of Zurich

Brief Summary

EBI2 is a risk gene for inflammatory bowel diseases (rs9557195). Patients of the Swiss IBD cohort study have been genotyped for the allelic status of EBI2. The investigators will test the influence of rs9557195 genoty (TT or CC allel), inflammatory activity and current treatment (infliximab vs. vedolizumab) on expression and activity of EBI2 on blood lymphocytes, mRNA expression of EBI2 and UBAC2 (located on the opposite DNA strand of EBI2) and activity of lymphocytes on a migraton assay.

Detailed Description

EBI2 is a risk gene for inflammatory bowel diseases (rs9557195). EBI2 is a G protein coupled receptors expressed on the immune cells. EBI2 directs migration and activity of immune cells.

Patients of the Swiss IBD cohort study have been genotyped for the allelic status of EBI2. The investigators will recruit patients with Crohn's disease and ulcerative colitis, assess epidemiological and clinical parameters (including clinical activity of IBD) draw blood, isolate lymphocytes, DNA and RNA.

The investigators will test the influence of rs9557195 genotype (TT or CC allel), inflammatory activity and current treatment (infliximab vs. vedolizumab) on expression and activity of EBI2 on blood lymphocytes (by FACS using an EBI2-antibody), mRNA expression (by qPCR) of EBI2 and UBAC2 (located on the opposite DNA strand of EBI2) and activity of lymphocytes on a migration assay.

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2018-07-02
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-16
• Last Update Submitted: 2018-08-17
• Last Update Posted: 2018-08-21
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

• Patient with IBD OR healthy volunteer
• No major uncontrolled medical/ surgical/ psychiatric condition requiring ongoing management besides IBD in the respective study groups. Well controlled conditions (i.e. medically controlled arterial hypertension, occupational asthma) may be present

Exclusion Criteria

none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EBI2 expression - dependent on rs9557195 allele status (FACS)	at time of inclusion into the study	EBI2 levels in PBMCs will be determined by FACS, and compared according to allele status of rs9557195

Secondary Outcome Measures

Name	Time	Method
Motility of PBMCs dependent on rs9557195 allele status (Boyden chamber)	at time of inclusion into the study	motility of PBMCs will be assessed using the Boyden chamber and compared according to allele status of rs9557195
EBI2 expression - dependent on rs9557195 allele status (RT-PCR)	at time of inclusion into the study	EBI2 levels in PBMCs will be determined by RT-PCR, and compared according to EBI2 levels in PBMCs will be determined by RT-PCR, and compared according to allele status of rs9557195
UBAC2 expression - dependent on rs9557195 allele status (RT-PCR)	at time of inclusion into the study	UBAC2 levels in PBMCs will be determined by RT-PCR, and compared according to 2 levels in PBMCs will be determined by RT-PCR, and compared according to allele status of rs9557195
EBI2-expression (FACS) in individuals treated with infliximab vs. vedolizumab	at time of inclusion into the study	We will compare EBI2 expression as determined by FACS in individuals with infliximab and vedolizumab treatment
EBI2-expression (FACS) according to gut inflammation	at time of inclusion into the study	We will compare EBI2 expression (determined by FACS) in IBD patients with severe disease, in remission and in healthy volunteers

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland