Biomarkers in Inflammatory Bowel Diseases

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.

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Key information

Conditions

Inflammatory Bowel Disease Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Odense University Hospital

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

Serum markers of extracellular matrix proteins (C1M, C3M, C4M, C5M, P1NP, VICM, P1NP, EL-NE, BGM and Pro-C5)

Time frame: Follow-up of 1 year for patients with active IBD. For all other groups the study are cross-sectional

The biomarkers are evaluated in relation to type of disease and disease activity.

Sponsors and collaborators

Lead sponsor

Line Elberg Godskesen

Other

Collaborators

University of Southern Denmark

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2019
First posted: Nov 23, 2015
Registry last updated: Oct 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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