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NCT00516776 Clinical Trial

The Innate Immune System and Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:
The Innate Immune System and Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00516776
Other study ID # 5.2007.910
Secondary ID
Status Completed
Phase N/A
First received August 14, 2007
Last updated February 12, 2018
Start date June 2007
Est. completion date December 2017

Study information
Verified date February 2018
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study includes individuals with ulcerative colitis, Crohn's disease and healthy controls. The purpose of this study is to examine the innate immune system (IIS) by exposing peripheral blood monocytes to various ligands relevant for stimulation of the IIS and study the immune response. Colonic mucosal samples are examined to find gene expression patterns which may distinguish the two forms of disease from each other and from healthy controls.

The hypothesis is that the innate immune system has responses unique for the disease states, and that the diseases may be differentiated by examination of gene expression patterns in mucosal biopsies.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Presence of ulcerative colitis

- Presence of Crohn's disease

- Healthy (no sign of inflammatory bowel disease)

Exclusion Criteria:

- Anticoagulation

- Cardiac valvular disease

- Intravascular prosthesis

- Coagulation disorders

- Gastrointestinal malignancy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Dept of Cancer Research and Molecular Medicine, NTNU Trondheim

Sponsors (2)
Lead Sponsor Collaborator
Norwegian University of Science and Technology The Royal Norwegian Ministry of Health

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary gene expression patterns in mucosal biopsies 2 years
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