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Differential EBI2 Expression Upon Allelic Status of the rs9557195 Polymorphism

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ClinicalTrials.gov Identifier: NCT03633409
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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.


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Study Type : Observational
Estimated 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 : November 1, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

Group/Cohort
IBD patients and healthy volunteers
We will recruit IBD patients and healthy volunteers



Primary Outcome Measures :
  1. EBI2 expression - dependent on rs9557195 allele status (FACS) [ Time Frame: 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 :
  1. EBI2 expression - dependent on rs9557195 allele status (RT-PCR) [ Time Frame: 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

  2. UBAC2 expression - dependent on rs9557195 allele status (RT-PCR) [ Time Frame: 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

  3. Motility of PBMCs dependent on rs9557195 allele status (Boyden chamber) [ Time Frame: 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

  4. EBI2-expression (FACS) in individuals treated with infliximab vs. vedolizumab [ Time Frame: at time of inclusion into the study ]
    We will compare EBI2 expression as determined by FACS in individuals with infliximab and vedolizumab treatment

  5. EBI2-expression (FACS) according to gut inflammation [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
peripheral blood mononuclear cells


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633409


Contacts
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Contact: Benjamin Misselwitz, MD +41 44 255 1111 benjamin.misselwitz@usz.ch
Contact: Rene Roth, MD +41 44 255 1111 rene.roth@usz.ch

Locations
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Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Benjamin Misselwitz, MD    ++41 44 255 1111    benjamin.misselwitz@usz.ch   
Contact: Rene Roth, MD    ++41 44 255 1111    rene.roth@usz.ch   
Sponsors and Collaborators
University of Zurich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03633409     History of Changes
Other Study ID Numbers: EBI2-Study
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: some of the outcome measures (EBI2 expression, cell motility assays) will be performed by external collaborators

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
IBD
EBI2
G protein coupled receptor
FACS
UBAC2
lymphocyte migration
single nucleotide polymorphism
Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis