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NCT03662646 Clinical Trial

Circadian Rhythms in Patients With IBD or Celiac Disease Upon Diagnosis and Medical Follow-up

Inflammatory Bowel Diseases Clinical Trial

Official title:
Clock Gene Disruption May be an Initial Manifestation of IBD and Celiac .

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03662646
Other study ID # TASMAC-16-YW-0200-CTIL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 31, 2017
Est. completion date December 31, 2022

Study information
Verified date February 2023
Source Tel-Aviv Sourasky Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date December 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender All
Age group 6 Years to 25 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervention performed- observational only
no intervention performed- observational only

Locations
Country Name City State
Israel Tel Aviv Sourasky Medical Center Tel Aviv

Sponsors (1)
Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary clock gene expression levels in intestinal mucosal samples and WBC peripheral blood. PCR amplification levels 4 years
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