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NCT01266538 Clinical Trial

Inflammatory Bowel Disease(IBD)Database

Inflammatory Bowel Disease Clinical Trial

— IBD  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01266538
Other study ID # TASMC-10-ID-467-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 23, 2010
Last updated December 23, 2010
Start date January 2011
Est. completion date December 2026

Study information
Verified date December 2010
Source Tel-Aviv Sourasky Medical Center
Contact Iris Dotan, MD PhD
Phone 972-3-6947305
Email irisd@tasmc.health.gov.il
Is FDA regulated No
Health authority Israel: The Israeli National Health Institute
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 2500
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Tel Aviv Sourasky Medical Center Tel Aviv

Sponsors (1)
Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary flactuations in gastrointestinal inflammation ongoing, up to 4 times a year No
Secondary development of IBD-related morbidity and complications over time ongoing, up to 4 times a year No
See also
  Status Clinical Trial Phase
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Terminated NCT00061282 - Clotrimazole Enemas for Pouchitis in Children and Adults Phase 1/Phase 2
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Completed NCT03264690 - Study to Observe the Change in Microbiome in Human Derived Sample and the Relation With Clinical Response Before and After the Anti-TNF Treatment in IBD Patients
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Completed NCT02161640 - Vascular Dysfunction in Paediatric IBD N/A
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Completed NCT02503696 - Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD) N/A
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