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

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Bo-In Lee

Status

Unknown

Conditions

Irritable Bowel Syndrome
Inflammatory Bowel Diseases

Treatments

Other: IBS or Normal Control
Other: inflammatory bowel disease

Study type

Observational

Funder types

Other

Identifiers

NCT03778918
XC18TEDI0027

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

19 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • people who receive colonoscopy
  • people who sign the consent
  • having inflammatory bowel disease (ulcerative colitis, Crohn's Dz.) and irritable bowel syndrome

Exclusion criteria

  • those aged over 75 years
  • the disabled
  • pregnant women
  • chronic renal diseases (CLcr <50ml/min)
  • blood coagulopathy (PT INR > 1.5, aPTT > 45 seconds, or platelet count < 50,000/mm)
  • people who refuse to sign the consent

Trial design

200 participants in 2 patient groups

inflammatory bowel disease
Description:
inflammatory bowel disease such as Ulcerative colitis and Crohn's disease
Treatment:
Other: inflammatory bowel disease
Other: IBS or Normal Control
IBS or Normal Control
Description:
irritable bowel syndrome patients normal patients
Treatment:
Other: inflammatory bowel disease
Other: IBS or Normal Control

Trial contacts and locations

1

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Central trial contact

Seungjun Kim, MD.; Bo-In Lee, MD. Ph.D.

Data sourced from clinicaltrials.gov

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