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The Innate Immune System and Inflammatory Bowel Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Royal Norwegian Ministry of Health
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00516776
First received: August 14, 2007
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition
Ulcerative Colitis
Crohn's Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Innate Immune System and Inflammatory Bowel Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • gene expression patterns in mucosal biopsies [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Intestinal biopsies Plasma/serum Peripheral blood monocytes


Estimated Enrollment: 400
Study Start Date: June 2007
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients from endoscopy unit and outpatients clinic with ulcerative colitis, Crohn's disease and healthy controls

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516776

Locations
Norway
Dept of Cancer Research and Molecular Medicine, NTNU
Trondheim, Norway, NO-7489
Sponsors and Collaborators
Norwegian University of Science and Technology
The Royal Norwegian Ministry of Health
Investigators
Principal Investigator: Arne K Sandvik, MD PhD Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00516776     History of Changes
Other Study ID Numbers: 5.2007.910
Study First Received: August 14, 2007
Last Updated: April 8, 2013
Health Authority: Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013