Circadian Rhythms in IBD Patients Upon Diagnosis and Medical Follow-up

• Sponsor: Tel-Aviv Sourasky Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03662646
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Actual Duration (Months): 52
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

patients under the age of 15 years old upon diagnostic evaluation will be recruited .

study population will comprise of two groups: newly diagnosed IBD patients 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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases; Circadian Dysregulation	Other: no intervention performed- observational only

Study Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Clock Gene Disruption May be an Initial Manifestation of IBD.
• Actual Study Start Date: Aug 31, 2017
• Actual Primary Completion Date: Aug 31, 2021
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
IBD patients	Other: no intervention performed- observational only; no intervention performed- observational only
Healthy controls	Other: no intervention performed- observational only; no intervention performed- observational only

Outcome Measures

Primary Outcome Measures

1. clock gene expression levels in intestinal mucosal samples and WBC peripheral blood. [4 years]

   PCR amplification levels

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• IBD patients with a confirmed 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tel Aviv Sourasky Medical Center	Tel Aviv		Israel	64239

Sponsors and Collaborators

• Tel-Aviv Sourasky Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Sprecher, MD, Dr. Yael Weintraub, Tel-Aviv Sourasky Medical Center
• ClinicalTrials.gov Identifier: NCT03662646
• Other Study ID Numbers: TASMAC-16-YW-0200-CTIL
• First Posted: Sep 7, 2018
• Last Update Posted: Mar 22, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Inflammatory Bowel Diseases; Chronobiology Disorders

Study Results

No Results Posted as of Mar 22, 2022