Biomarkers in Inflammatory Bowel Diseases

Line Elberg Godskesen

Status: Completed

Conditions: Colitis, Ulcerative; Inflammatory Bowel Disease; Crohn Disease

Study type: Observational

Funder types: Other

Identifiers

NCT02612103

S-20150107

Details and patient eligibility

About

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.

Enrollment: 193 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

193 participants in 6 patient groups

Active Crohns disease

Description:

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

Crohns disease in remission

Description:

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

Active ulcerative colitis

Description:

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

Ulcerative colitis in remission

Description:

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

Irritable bowel syndrome

Description:

Verified irritable bowel syndrome according to standard criteria.

Healthy controls

Description:

No known chronic diseases which needs continuously medication.