Clinical trial NCT02612103: Biomarkers in Inflammatory Bowel Diseases
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Colitis, Ulcerative
Crohn Disease
Keywords: Biochemical markers
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2015-11-23
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IBD and IBS patients at The Department of Medical Gastroenterology, Odense University Hospital will be asked to participate when they contact the department due to progression in disease activity or at their regular consultations in the out-patient clinic.

Healthy controls will be recruited by advertising in local news paper and advertising in public places.

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Serum markers of extracellular matrix proteins (C1M, C3M, C4M, C5M, P1NP, VICM, P1NP, EL-NE, BGM and Pro-C5)
timeFrame: Follow-up of 1 year for patients with active IBD. For all other groups the study are cross-sectional
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
References: