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Circadian Rhythms in IBD Patients Upon Diagnosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03662646
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : September 7, 2018
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

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
Inflammatory Bowel Diseases Circadian Dysregulation Other: no intervention performed- observational only

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Study Type : Observational
Estimated Enrollment : 60 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 : August 31, 2017
Actual Primary Completion Date : August 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

Group/Cohort 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

Primary Outcome Measures :
  1. clock gene expression levels in intestinal mucosal samples and WBC peripheral blood. [ Time Frame: two years ]
    PCR amplification levels

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients performing endoscopic procedures in our institute.

Inclusion Criteria:

- patients admitted to perform endoscopic workup for gastrointestinal complaints.

Exclusion Criteria:

  • 1. known and treated IBD. 2. current immunosupresive treatment. 3. genetic disorder. 4. known immunodeficiency. 5. pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03662646

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Contact: yael weintraub, md 972-3-6974159

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Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Gali Hgler-Price    972-3-694761   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: michal roll, Dr. Yael Weintraub, Tel-Aviv Sourasky Medical Center Identifier: NCT03662646    
Other Study ID Numbers: TASMAC-16-YW-0200-CTIL
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Chronobiology Disorders
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Nervous System Diseases