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The Innate Immune System and Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT00516776
Recruitment Status : Completed
First Posted : August 15, 2007
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
The Royal Norwegian Ministry of Health
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.


Condition or disease
Ulcerative Colitis Crohn's Disease

Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Innate Immune System and Inflammatory Bowel Disease
Actual Study Start Date : June 2007
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

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


Information from the National Library of Medicine

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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

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


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

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 Posted: August 15, 2007    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
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