Inflammatory Bowel DiseaseIBDNCT01266538
Inflammatory Bowel Disease(IBD)Database
An observational study of Inflammatory Bowel Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
This will be a comprehensive epidemiological, clinical, endoscopic and histological database for inflammatory bowel diseases patients in our medical center that will further provide clinical and basic investigations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease
- How many people
- 2,500 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Cases: Patients diagnosed with Inflammatory Bowel Disease (IBD) attending the departement of Gastroenterology (Tel Aviv Sourasky Medical Center) for a regular follow up / treatment. 2. Controls:Family members of IBD patients, Patients with Irritable Bowel Syndrome (IBS), Fap (familial polyposis)patients after a large bowel resection, Patient performing screening endoscopy --------------------------------------------------------------------------------
Who may be able to join
- Diagnosis of IBD Regular treatment and follow up in Tel Aviv Sourasky medical center Fap (familial polyposis)patients after a large bowel resection, as controls Family members of IBD patients as controls Patients with Irritable Bowel Syndrome (IBS), as controls -
Who cannot join
- pregnancy age<18 years
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Hagit Tulchinsky, MD
Henit Yanai, MD
About this study
Official title: Epidemiologic, Clinical, Endoscopic and Histological Database of Patients With Inflammatory Bowel Disease (IBD)
This will be a comprehensive epidemiological, clinical, endoscopic and histological database for inflammatory bowel diseases patients in our medical center that will further provide clinical and basic investigations.
Read the detailed description
Inflammatory bowel diseases (IBD), which include Crohn's disease (CD), ulcerative colitis (UC), undefined IBD and pouchitis (in patients who required IPAA for their colitis) affects about two million people in the world. At this time there is no definitive cure and current treatment is aimed at managing the symptoms and inflammation that accompany these diseases. These diseases are predominantly chronic, and patients may experience various gastrointestinal symptoms depending on the location, nature, and extent of their disease. Both genetic and environmental factors play etiological roles. The overall goal of our research is to understand the etiology and course of these diseases in order to prevent and to manage cases more effectively. In order to do so we are aiming at building a comprehensive database that will include detailed clinical data conjoined with dedicated research information and collection of biological specimens that will target the gut epithelium immune system, the microbiota and specific genetic risk factors.
- Conditions
- Inflammatory Bowel Disease
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBD patients | Patients diagnosed with Inflammatory Bowel Disease (IBD) | |
| patients after a Large Bowel Resection | Patients after a Large Bowel Resection, with or without a pouch. | |
| Control group | Family members of IBD patients, Patients with Irritable Bowel Syndrome (IBS), Fap (familial polyposis)patients after a large bowel resection, Patient performing screening endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
flactuations in gastrointestinal inflammation
Measured: ongoing, up to 4 times a year
Secondary outcomes (1)
development of IBD-related morbidity and complications over time
Measured: ongoing, up to 4 times a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Iris Dotan, MD PhD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266538
- Sponsor's protocol ID
- TASMC-10-ID-467-CTIL
- Acronym
- IBD
- Status last verified
- Dec 2010
- First submitted
- 23 Dec 2010
- Last updated
- 24 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic, Clinical, Endoscopic and Histological Database of Patients With Inflammatory Bowel Disease (IBD)
- ClinicalTrials.gov ID
- NCT01266538
- Acronym / sponsor ID
- IBD / TASMC-10-ID-467-CTIL
- Conditions
- Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2011
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Dec 2010 (estimated)
- 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.
This will be a comprehensive epidemiological, clinical, endoscopic and histological database for inflammatory bowel diseases patients in our medical center that will further provide clinical and basic investigations.
Detailed description
Inflammatory bowel diseases (IBD), which include Crohn's disease (CD), ulcerative colitis (UC), undefined IBD and pouchitis (in patients who required IPAA for their colitis) affects about two million people in the world. At this time there is no definitive cure and current treatment is aimed at managing the symptoms and inflammation that accompany these diseases. These diseases are predominantly chronic, and patients may experience various gastrointestinal symptoms depending on the location, nature, and extent of their disease. Both genetic and environmental factors play etiological roles. The overall goal of our research is to understand the etiology and course of these diseases in order to prevent and to manage cases more effectively. In order to do so we are aiming at building a comprehensive database that will include detailed clinical data conjoined with dedicated research information and collection of biological specimens that will target the gut epithelium immune system, the microbiota and specific genetic risk factors.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBD patients | – | –Patients diagnosed with Inflammatory Bowel Disease (IBD) |
| patients after a Large Bowel Resection | – | –Patients after a Large Bowel Resection, with or without a pouch. |
| Control group | – | –Family members of IBD patients, Patients with Irritable Bowel Syndrome (IBS), Fap (familial polyposis)patients after a large bowel resection, Patient performing screening endoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Cases: Patients diagnosed with Inflammatory Bowel Disease (IBD) attending the departement of Gastroenterology (Tel Aviv Sourasky Medical Center) for a regular follow up / treatment. 2. Controls:Family members of IBD patients, Patients with Irritable Bowel Syndrome (IBS), Fap (familial polyposis)patients after a large bowel resection, Patient performing screening endoscopy --------------------------------------------------------------------------------
Key inclusion criteria (1 listed)
- Diagnosis of IBD Regular treatment and follow up in Tel Aviv Sourasky medical center Fap (familial polyposis)patients after a large bowel resection, as controls Family members of IBD patients as controls Patients with Irritable Bowel Syndrome (IBS), as controls -
Key exclusion criteria (2 listed)
- pregnancy age<18 years
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
flactuations in gastrointestinal inflammation
Time frame: ongoing, up to 4 times a year
1 secondary outcome
development of IBD-related morbidity and complications over time
Time frame: ongoing, up to 4 times a year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2010.
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CT Based Assessment of Sarcopenia and Its Association With Biologic Treatment Outcomes in Inflammatory Bowel Disease Patients
CT-Assessed Sarcopenia Outcomes
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Weight and BMI Patterns in Biological Based IBD Patients and Its Finacial Impact
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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.
Iris Dotan, MD PhD principal investigator
Tel-Aviv Sourasky Medical Center
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 Disease, 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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 24 Dec 2010. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iris Dotan, MD PhD (972-3-6947305, irisd@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
flactuations in gastrointestinal inflammation (time frame: ongoing, up to 4 times a year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2010.