Inflammatory Bowel Disease(IBD)Database (IBD)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

• Study Contact: Name: Iris Dotan, MD PhD; Phone Number: 972-3-6947305; Email: irisd@tasmc.health.gov.il

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center
    • Sub-Investigator: Hagit Tulchinsky, MD
    • Sub-Investigator: Henit Yanai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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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Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
flactuations in gastrointestinal inflammation	ongoing, up to 4 times a year

Secondary Outcome Measures

Outcome Measure	Time Frame
development of IBD-related morbidity and complications over time	ongoing, up to 4 times a year

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Iris Dotan, MD PhD, Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: December 23, 2010
• First Submitted That Met QC Criteria: December 23, 2010
• First Posted (Estimate): December 24, 2010

Study Record Updates

• Last Update Posted (Estimate): December 24, 2010
• Last Update Submitted That Met QC Criteria: December 23, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: TASMC-10-ID-467-CTIL