The Comparison Between the Biomarkers in Inflammatory Bowel Disease Patients and General Control Group
- Conditions
- Inflammatory Bowel DiseasesIrritable Bowel Syndrome
- Interventions
- Other: inflammatory bowel diseaseOther: IBS or Normal Control
- Registration Number
- NCT03778918
- Lead Sponsor
- Bo-In Lee
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- people who receive colonoscopy
- people who sign the consent
- having inflammatory bowel disease (ulcerative colitis, Crohn's Dz.) and irritable bowel syndrome
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description inflammatory bowel disease IBS or Normal Control inflammatory bowel disease such as Ulcerative colitis and Crohn's disease IBS or Normal Control IBS or Normal Control irritable bowel syndrome patients normal patients inflammatory bowel disease inflammatory bowel disease inflammatory bowel disease such as Ulcerative colitis and Crohn's disease IBS or Normal Control inflammatory bowel disease irritable bowel syndrome patients normal patients
- Primary Outcome Measures
Name Time Method measurement of blood-based biomarkers to predict disease activity 2 within 12 weeks of the blood sampling hs-CRP (mg/dL)
measurement of blood-based biomarkers to predict disease activity 1 within 12 weeks of the blood sampling REG3 alpha (ng/mL)
measurement of blood-based biomarkers to predict disease activity 3 within 12 weeks of the blood sampling serum calprotectin (ng/mL)
- Secondary Outcome Measures
Name Time Method Gender (M/F) at the time of study enrolled male of female
disease duration (months) at the time of study enrolled duration of disease
Age (years) at the time of study enrolled age at the time of study enrolled
disease onset (years) at the time of study enrolled age at which the disease begins
Trial Locations
- Locations (1)
Division of Gastroenterology; Seoul St. Mary's hospital
🇰🇷Seoul, Korea, Republic of