Inflammatory Bowel DiseasesNCT03633409
Differential EBI2 Expression Upon Allelic Status of the rs9557195 Polymorphism
An observational study of Inflammatory Bowel Diseases, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 340 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2017to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Benjamin Misselwitz, MD, ++41 44 255 1111, benjamin.misselwitz@usz.ch
Rene Roth, MD, ++41 44 255 1111, rene.roth@usz.ch
About this study
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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- IBD, EBI2, G protein coupled receptor, FACS, UBAC2, lymphocyte migration, single nucleotide polymorphism
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBD patients and healthy volunteers | We will recruit IBD patients and healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at time of inclusion into the study
Secondary outcomes (5)
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
Measured: at time of inclusion into the study
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
Measured: at time of inclusion into the study
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
Measured: at time of inclusion into the study
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
Measured: at time of inclusion into the study
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
Measured: at time of inclusion into the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start1 Nov 2017
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633409
- Sponsor's protocol ID
- EBI2-Study
- Status last verified
- Aug 2018
- First submitted
- 2 Jul 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: some of the outcome measures (EBI2 expression, cell motility assays) will be performed by external collaborators
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential EBI2 Expression Upon Allelic Status of the rs9557195 Polymorphism
- ClinicalTrials.gov ID
- NCT03633409
- Acronym / sponsor ID
- EBI2-Study
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- IBD, EBI2, G protein coupled receptor, FACS, UBAC2, lymphocyte migration, single nucleotide polymorphism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD patients and healthy volunteers | – | –We will recruit IBD patients and healthy volunteers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
EBI2 expression - dependent on rs9557195 allele status (RT-PCR)
Time frame: at time of inclusion into the study
UBAC2 expression - dependent on rs9557195 allele status (RT-PCR)
Time frame: at time of inclusion into the study
Motility of PBMCs dependent on rs9557195 allele status (Boyden chamber)
Time frame: at time of inclusion into the study
EBI2-expression (FACS) in individuals treated with infliximab vs. vedolizumab
Time frame: at time of inclusion into the study
EBI2-expression (FACS) according to gut inflammation
Time frame: at time of inclusion into the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Individual participant dataSharing planned: Undecided. some of the outcome measures (EBI2 expression, cell motility assays) will be performed by external collaborators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Misselwitz, MD (+41 44 255 1111, benjamin.misselwitz@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EBI2 expression - dependent on rs9557195 allele status (FACS) (time frame: at time of inclusion into the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.