The Innate Immune System and Inflammatory Bowel Disease

February 12, 2018 updated by: Norwegian University of Science and Technology

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, NO-7489
        • Dept of Cancer Research and Molecular Medicine, NTNU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
gene expression patterns in mucosal biopsies
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

The Royal Norwegian Ministry of Health

Investigators

  • Principal Investigator: Arne K Sandvik, MD PhD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2007

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

August 14, 2007

First Submitted That Met QC Criteria

August 14, 2007

First Posted (Estimate)

August 15, 2007

Study Record Updates

Last Update Posted (Actual)

February 14, 2018

Last Update Submitted That Met QC Criteria

February 12, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5.2007.910

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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