Biomarkers in Inflammatory Bowel Diseases

NCT02612103 | Completed

• 1 other identifier: S-20150107
• Study Type: observational
• Target: 193
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease; Colitis, Ulcerative; Crohn Disease

Keywords

Biochemical markers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (6)

Active Crohns disease

Verified Crohns disease diagnosis according to clinical, endoscopic and histological standard criteria and Harvey Bradshaw index \> 4.

Crohns disease in remission

Verified Crohns disease diagnosis according to clinical, endoscopic and histological standard criteria and Harvey Bradshaw index ≤ 4.

Active ulcerative colitis

Verified ulcerative colitis diagnosis according to clinical, endoscopic and histological standard criteria and Simple Clinical Colitis Activity Index \> 3.

Ulcerative colitis in remission

Verified ulcerative colitis diagnosis according to clinical, endoscopic and histological standard criteria and Simple Clinical Colitis Activity Index ≤ 3.

Irritable bowel syndrome

Verified irritable bowel syndrome according to standard criteria.

Healthy controls

No known chronic diseases which needs continuously medication.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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 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).

Sponsors & Collaborators

• Line Elberg Godskesen: lead
• University of Southern Denmark: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD-student

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: November 23, 2015
• Study Start: November 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2019
• Last Updated: October 25, 2019

Record last verified: 2018-03

Locations

DK (1)