NCT03778918

The Comparison Between the Biomarkers in Inflammatory Bowel Disease Patients and General Control Group

The Comparison Between That Expression Pattern and Disease Activity of Variable Biomarkers in Inflammatory Bowel Disease Patients and General Control Group. Multicenter, Prospective Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Bo-In Lee · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The aims of this study is to investigate a blood-based biomarker that can replace endoscopy in patients with inflammatory bowel disease. For this purpose, blood sample of patients wiht inflammatory bowel disease (ulcerative colitis, Crohn 's disease) was collected at the same time the endoscopy is performed, stored after centrifugation, and analyzed accordingly. Selected biomarkers from the blood sample were investigated to compare those of patients with inflammatory bowel disease and those of general controls. Males and females over the age of 19 participated in the study and are excluded if they have chronic kidney disease or blood clotting disease. The outcome is a find of a blood-based biomarker that best reflects a disease activity.

Detailed description

Inflammatory bowel disease refers to chronic inflammation of the unknown origin that occurs in the intestine. It usually refers to ulcerative colitis and Crohn's disease, which are idiopathic inflammatory bowel diseases. While it had been known to be a common disease in the western world, in recent decades the incidence of ulcerative colitis and Crohn's disease has rapidly increased in Korea as well. Endoscopic examination is a gold standard in order to determine the activity of inflammatory bowel disease, but it is hardly performed due to the cost and time of a test. Therefore, it is necessary to find a blood-based biomarker that replaces endoscopy. The objective of the study is to identify a new inflammatory marker that replaces endoscopy by comparing blood samples of patients with inflammatory bowel disease with those of general controls.

Conditions

• Inflammatory Bowel Diseases
• Irritable Bowel Syndrome

Interventions

Type	Name	Description
OTHER	inflammatory bowel disease	blood based biomarkers in IBD such as REG3 alpha, serum calprotectin and hs-CRP
OTHER	IBS or Normal Control	blood based biomarker compared normal control with IBD

Timeline

• Start date: 2016-08-01
• Primary completion: 2020-06-30
• Completion: 2020-12-30
• First posted: 2018-12-19
• Last updated: 2020-03-03

Locations

1 site across 1 country: South Korea