Differential EBI2 Expression Upon Allelic Status of the rs9557195 Polymorphism

Inflammatory Bowel Diseases Clinical Trial

Official title:

Differential EBI2 Expression Upon Allelic Status of the rs9557195 Polymorphism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03633409
• Other study ID #: EBI2-Study
• Status: Recruiting
• Start date: November 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: August 2018
• Source: University of Zurich
• Contact: Benjamin Misselwitz, MD
• Phone: +41 44 255 1111
• Email: benjamin.misselwitz[@]usz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

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