Differential EBI2 Expression Upon Allelic Status of the rs9557195 Polymorphism

NCT03633409 | Unknown

• 1 other identifier: EBI2-Study
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Keywords

IBD; EBI2; G protein coupled receptor; FACS; UBAC2; lymphocyte migration; single nucleotide polymorphism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• EBI2 expression - dependent on rs9557195 allele status (RT-PCR)

  at time of inclusion into the study

• UBAC2 expression - dependent on rs9557195 allele status (RT-PCR)

  at time of inclusion into the study

• Motility of PBMCs dependent on rs9557195 allele status (Boyden chamber)

  at time of inclusion into the study

• EBI2-expression (FACS) in individuals treated with infliximab vs. vedolizumab

  at time of inclusion into the study

• EBI2-expression (FACS) according to gut inflammation

  at time of inclusion into the study

Study Arms (1)

IBD patients and healthy volunteers

We will recruit IBD patients and healthy volunteers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

we will recruit a mixed population (patients can be in more than one group) * up to 100 healthy volunteers * up to 30 IBD patients with the rs9557195-CC IBD risk genotype in clinical remission * up to 30 IBD patients with the rs9557195-CT IBD risk genotype in clinical remission * up to 30 IBD patients with the rs9557195-TT IBD low risk genotype in clinical remission * up to 50 IBD patients of any genotype during a flare * up to 50 IBD patients of any genotype treated with vedolizumab * up to 50 IBD patients of any genotype treated with a TNF-inhibitor (infliximab, adalimumab, golimumab, certolizumab)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood mononuclear cells

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Benjamin Misselwitz, MD

CONTACT

+41 44 255 1111; benjamin.misselwitz@usz.ch

Rene Roth, MD

CONTACT

+41 44 255 1111; rene.roth@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: August 16, 2018
• Study Start: November 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

CH (1)