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Not yet recruiting NCT01266538

Inflammatory Bowel Disease(IBD)Database

Observational Inflammatory Bowel Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Epidemiologic, Clinical, Endoscopic and Histological Database of Patients With Inflammatory Bowel Disease (IBD)

Overview

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.

Primary outcome measures

  • 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]

Eligibility 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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study locations

Israel · 1 center
  • Tel Aviv Sourasky Medical Center — Tel Aviv

Identifiers

NCT: NCT01266538 · TASMC-10-ID-467-CTIL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗