Inflammatory Bowel Disease(IBD)Database

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2010 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01266538
First received: December 23, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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
Inflammatory Bowel Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Epidemiologic, Clinical, Endoscopic and Histological Database of Patients With Inflammatory Bowel Disease (IBD)

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • flactuations in gastrointestinal inflammation [ Time Frame: ongoing, up to 4 times a year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • development of IBD-related morbidity and complications over time [ Time Frame: ongoing, up to 4 times a year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood serum, gastrointestinal biopsies, fecal samples


Estimated Enrollment: 2500
Study Start Date: January 2011
Estimated Study Completion Date: December 2026
Estimated Primary Completion Date: December 2026 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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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

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  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 23, 2010
Last Updated: December 23, 2010
Health Authority: Israel: The Israeli National Health Institute

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

ClinicalTrials.gov processed this record on August 26, 2014