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Inflammatory Bowel Disease(IBD)Database (IBD)

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ClinicalTrials.gov Identifier: NCT01266538
Recruitment Status : Not yet recruiting
First Posted : December 24, 2010
Last Update Posted : December 24, 2010
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease
Inflammatory Bowel Disease

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

Study Type : Observational
Estimated Enrollment : 2500 participants
Time Perspective: Prospective
Official Title: Epidemiologic, Clinical, Endoscopic and Histological Database of Patients With Inflammatory Bowel Disease (IBD)
Study Start Date : January 2011
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026
Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. flactuations in gastrointestinal inflammation [ Time Frame: ongoing, up to 4 times a year ]

Secondary Outcome Measures :
  1. development of IBD-related morbidity and complications over time [ Time Frame: ongoing, up to 4 times a year ]

Biospecimen Retention:   Samples Without DNA
blood serum, gastrointestinal biopsies, fecal samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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

Criteria

Inclusion Criteria:

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 -

Exclusion Criteria:

pregnancy age<18 years

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01266538


Contacts
Contact: Iris Dotan, MD PhD 972-3-6947305 irisd@tasmc.health.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Sub-Investigator: Hagit Tulchinsky, MD         
Sub-Investigator: Henit Yanai, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Iris Dotan, MD PhD Tel-Aviv Sourasky Medical Center
More Information

Responsible Party: Dr. Iris Dotan, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01266538     History of Changes
Other Study ID Numbers: TASMC-10-ID-467-CTIL
First Posted: December 24, 2010    Key Record Dates
Last Update Posted: December 24, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis