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

NCT ID: NCT03662646

Last Updated: 2023-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-31

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Inflammatory Bowel Diseases Circadian Dysregulation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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IBD patients

no intervention performed- observational only

Intervention Type OTHER

no intervention performed- observational only

Healthy controls

no intervention performed- observational only

Intervention Type OTHER

no intervention performed- observational only

Interventions

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no intervention performed- observational only

no intervention performed- observational only

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Eli Sprecher, MD

Dr. Yael Weintraub, Prof. Shlomi Cohen

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

References

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Weintraub Y, Cohen S, Yerushalmy-Feler A, Chapnik N, Tsameret S, Anafy A, Damari E, Ben-Tov A, Shamir R, Froy O. Circadian clock gene disruption in white blood cells of patients with celiac disease. Biochimie. 2024 Apr;219:51-54. doi: 10.1016/j.biochi.2023.07.020. Epub 2023 Jul 29.

Reference Type DERIVED
PMID: 37524198 (View on PubMed)

Weintraub Y, Cohen S, Anafy A, Chapnik N, Tsameret S, Ben-Tov A, Yerushalmy-Feler A, Dotan I, Tauman R, Froy O. Inverse Relationship Between Clock Gene Expression and Inflammatory Markers in Ulcerative Colitis Patients Undergoing Remission. Dig Dis Sci. 2023 Jun;68(6):2454-2462. doi: 10.1007/s10620-023-07847-y. Epub 2023 Feb 6.

Reference Type DERIVED
PMID: 36745299 (View on PubMed)

Weintraub Y, Cohen S, Chapnik N, Ben-Tov A, Yerushalmy-Feler A, Dotan I, Tauman R, Froy O. Clock Gene Disruption Is an Initial Manifestation of Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2020 Jan;18(1):115-122.e1. doi: 10.1016/j.cgh.2019.04.013. Epub 2019 Apr 10.

Reference Type DERIVED
PMID: 30981000 (View on PubMed)

Other Identifiers

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TASMAC-16-YW-0200-CTIL

Identifier Type: -

Identifier Source: org_study_id

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