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The Innate Immune System and Inflammatory Bowel Disease

This study is currently recruiting participants.
Verified August 2017 by Norwegian University of Science and Technology
Sponsor:
ClinicalTrials.gov Identifier:
NCT00516776
First Posted: August 15, 2007
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
The Royal Norwegian Ministry of Health
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  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:


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

Primary Outcome Measures:
  • gene expression patterns in mucosal biopsies [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Intestinal biopsies Plasma/serum Peripheral blood monocytes

Estimated Enrollment: 400
Actual Study Start Date: June 2007
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516776


Contacts
Contact: Arne K Sandvik, MD PhD +47 73598808 arne.sandvik@ntnu.no
Contact: Helge L Waldum, MD PhD +47 73868541 helge.waldum@ntnu.no

Locations
Norway
Dept of Cancer Research and Molecular Medicine, NTNU Recruiting
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00516776     History of Changes
Other Study ID Numbers: 5.2007.910
First Submitted: August 14, 2007
First Posted: August 15, 2007
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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