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

Completed

• Conditions: Inflammatory Bowel Diseases; Circadian Dysregulation

• Registration Number: NCT03662646
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-31
• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-07
• Primary Completion: 2022-07-31
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-20
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
clock gene expression levels in intestinal mucosal samples and WBC peripheral blood.	4 years	PCR amplification levels

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel