Biomarkers in Inflammatory Bowel Diseases

NCT ID: NCT02612103

Last Updated: 2019-10-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 193 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-06-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Active Crohns disease

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

No interventions assigned to this group

Crohns disease in remission

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

No interventions assigned to this group

Active ulcerative colitis

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

No interventions assigned to this group

Ulcerative colitis in remission

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

No interventions assigned to this group

Irritable bowel syndrome

Verified irritable bowel syndrome according to standard criteria.

No interventions assigned to this group

Healthy controls

No known chronic diseases which needs continuously medication.

No interventions assigned to this group

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Line Elberg Godskesen

OTHER

Sponsor Role: lead

Responsible Party

Line Elberg Godskesen

MD, PhD-student

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Odense University Hospital

Odense, , Denmark

Countries

Denmark

Other Identifiers

S-20150107

Identifier Type: -

Identifier Source: org_study_id