Inflammatory Bowel DiseasesNCT03662646
Circadian Rhythms in Patients With IBD or Celiac Disease Upon Diagnosis and Medical Follow-up
An observational study of Inflammatory Bowel Diseases and Circadian Dysregulation, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 6 to 25 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Circadian Dysregulation
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 31 Aug 2017to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients medically treated in our institute.
Who may be able to join
- 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.
Who cannot join
- Genetic disorder.
- Known primary or secondary immunodeficiency .
- Pregnancy or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clock Gene Disruption May be an Initial Manifestation of IBD and Celiac .
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.
- Being tested
- no intervention performed- observational only
- Medical subject headings
- Inflammatory Bowel Diseases, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention performed- observational onlyOther
no intervention performed- observational only
| Study group | Role | What they receive |
|---|---|---|
| IBD patients | Not described Receives: Other: no intervention performed- observational only | |
| Healthy controls | Not described Receives: Other: no intervention performed- observational only |
What is being measured
The primary outcome is the main question the study is designed to answer.
clock gene expression levels in intestinal mucosal samples and WBC peripheral blood.
PCR amplification levels
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start31 Aug 2017
- Primary completion31 Jul 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662646
- Sponsor's protocol ID
- TASMAC-16-YW-0200-CTIL
- Status last verified
- Feb 2023
- First submitted
- 5 Sep 2018
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37524198Weintraub 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.
PubMed 36745299Weintraub 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.
PubMed 30981000
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clock Gene Disruption May be an Initial Manifestation of IBD and Celiac .
- ClinicalTrials.gov ID
- NCT03662646
- Acronym / sponsor ID
- TASMAC-16-YW-0200-CTIL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD patients | – | Other: no intervention performed- observational only |
| Healthy controls | – | Other: no intervention performed- observational only |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients medically treated in our institute.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Genetic disorder.
- Known primary or secondary immunodeficiency .
- Pregnancy or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention performed- observational onlyno intervention performed- observational only | Other | Healthy controls, IBD patients |
Primary outcome
clock gene expression levels in intestinal mucosal samples and WBC peripheral blood.
Time frame: 4 years
PCR amplification levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Derived from this study: PubMed 37524198Weintraub 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.
- Derived from this study: PubMed 36745299Weintraub 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.
- Derived from this study: PubMed 30981000Weintraub 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Circadian Dysregulation, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clock gene expression levels in intestinal mucosal samples and WBC peripheral blood. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03662646, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.