Differential EBI2 Expression Upon Allelic Status of the rs9557195 Polymorphism

Sponsor

University of Zurich (Other)

Overall Status

Unknown status

CT.gov ID

NCT03633409

Collaborator

(none)

340

Enrollment

Location

Anticipated Duration (Months)

26.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases

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 Design

Study Type:

Observational

Anticipated Enrollment :

340 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Differential EBI2 Expression Upon Allelic Status of the rs9557195 Polymorphism

Actual Study Start Date :

Nov 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
IBD patients and healthy volunteers We will recruit IBD patients and healthy volunteers

Outcome Measures

Primary Outcome Measures

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

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
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 (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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

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