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Clinical Trials/NCT00516776
NCT00516776CompletedNot Applicable

The Innate Immune System and Inflammatory Bowel Disease

Norwegian University of Science and Technology1 site in 1 country400 target enrollmentStarted: June 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
400
Locations
1
Primary Endpoint
gene expression patterns in mucosal biopsies

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

gene expression patterns in mucosal biopsies

Time Frame: 2 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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