- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03662646
Circadian Rhythms in Patients With IBD or Celiac Disease Upon Diagnosis and Medical Follow-up
Clock Gene Disruption May be an Initial Manifestation of IBD and Celiac .
patients 6-25 years old upon diagnostic evaluation will be recruited . study population will comprise of two groups: newly diagnosed IBD patients/ Celiac disease and healthy controls.
upon enrollment, subjects will fill out sleeping habits questioners, demographic data, medical history.
blood samples will be drawn for CRP and clock gene expression in systemic WBC. intestinal biopsies will be snap frozen for clock gene extraction and amplification only for patients with IBD.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Tel Aviv, Israel, 64239
- Tel Aviv Sourasky Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- IBD or celiac patients with a confirmed diagnosis, recruited upon diagnosis.
- Both male and female
- Age 6-25 years
- Medically treated for IBD in our institute.
Exclusion Criteria:
- Genetic disorder.
- Known primary or secondary immunodeficiency .
- Pregnancy or lactating
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
IBD patients
|
no intervention performed- observational only
|
Healthy controls
|
no intervention performed- observational only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clock gene expression levels in intestinal mucosal samples and WBC peripheral blood.
Time Frame: 4 years
|
PCR amplification levels
|
4 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMAC-16-YW-0200-CTIL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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