Biomarkers in Inflammatory Bowel Diseases

Crohn Disease Clinical Trial

Official title:

Evaluation of Markers of the Extracellular Matrix Turnover as Biomarkers in Inflammatory Bowel Diseases and Establishment of an Inflammatory Bowel Diseases (IBD) Biobank

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612103
• Other study ID #: S-20150107
• Status: Completed
• Start date: November 2015
• Est. completion date: June 2019

Study information

• Verified date: March 2018
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Ulcerative colitis (UC) and Crohn's disease (CD) are chronic relapsing inflammatory bowel diseases (IBD). At the time of diagnosis it is not possible to predict the course of the disease, which can range from a few flares in a lifetime to uncontrollable disease leading to hospitalization, surgery and stoma. There is a continuous need to improve diagnostic and prognostic tools.

In chronic inflammation diseases there is an excessive turnover of the extracellular tissue. Tissue is broken down to small fragments and released into the circulation. Changes in the amount of these fragments in the blood may provide information on the damage and quality of the affected tissue and may therefore act as objective measure of disease burden and severity

• a so called biomarker.

The potential of such biomarkers is evaluated in a combined cross-sectional and longitudinal survey including 300 patients with UC, CD, irritable bowel disease and healthy controls. The patients are followed for up to 1 year. Changes in biomarker are correlated to standard markers of inflammation during active disease and remission.

Perspective The use of new biomarkers may offer a tool to evaluate early changes in the gut of patients with IBD, may be a supplement to the diagnosis, serve as markers for effect of treatment and prognosis, and in time be a good alternative to fecal samples or endoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: June 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• Written informed consent

• and one of:

• for Crohn's disease - active disease: Verified CD diagnosis according to clinical, endoscopic and histological standard criteria and Harvey Bradshaw index > 4.

• for Crohn's disease - disease in remission: Verified CD diagnosis according to clinical, endoscopic and histological standard criteria and Harvey Bradshaw index = 4.

• Ulcerative colitis - active disease: Verified UC diagnosis according to clinical, endoscopic and histological standard criteria and SCCAI > 3.

• Ulcerative colitis - in remission: Verified UC diagnosis according to clinical, endoscopic and histological standard criteria and SCCAI = 3.

• Irritable bowel syndrome: Verified IBS according to standard criteria.

• Healthy control: No known chronic diseases which needs continuously medication.

Exclusion Criteria:

• Common to all participants:

• Patient with ostomy or pouch.

• The patient has had colon cancer, dysplasia or adenomatous polyps in the colon during the recent 5 year

• The patient is in a poor general condition.

• The patient is pregnant at the time of inclusion or has planned pregnancy during the period of study.

• The patient cannot understand the information material.

• Healthy control:

• The patient has a chronic disease.

• IBS symptoms according to standard criteria.

• The patient has had any type of illness within the last 14 days (for example diarrhea, a cold etc.).

• The patient has any type of on-going medication or new medication within the last 14 days (except contraceptive pills and vitamins).

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Line Elberg Godskesen	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum markers of extracellular matrix proteins (C1M, C3M, C4M, C5M, P1NP, VICM, P1NP, EL-NE, BGM and Pro-C5)	The biomarkers are evaluated in relation to type of disease and disease activity.	Follow-up of 1 year for patients with active IBD. For all other groups the study are cross-sectional