NCT01266538

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jan 2011Dec 2026

First Submitted

Initial submission to the registry

December 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2010

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
15.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 24, 2010

Status Verified

December 1, 2010

Enrollment Period

15.9 years

First QC Date

December 23, 2010

Last Update Submit

December 23, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • flactuations in gastrointestinal inflammation

    ongoing, up to 4 times a year

Secondary Outcomes (1)

  • development of IBD-related morbidity and complications over time

    ongoing, up to 4 times a year

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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 \--------------------------------------------------------------------------------

You may qualify if:

  • 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 -

You may not qualify if:

  • pregnancy age\<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood serum, gastrointestinal biopsies, fecal samples

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Iris Dotan, MD PhD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 23, 2010

First Posted

December 24, 2010

Study Start

January 1, 2011

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 24, 2010

Record last verified: 2010-12

Locations