Inflammatory Bowel Diseases, Irritable Bowel Syndrome
Conditions
Keywords
REG3 alpha, IBD, biomarker, ulcerative colitis, serum calprotectin
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.
Interventions
OTHERinflammatory bowel disease
blood based biomarkers in IBD such as REG3 alpha, serum calprotectin and hs-CRP
OTHERIBS or Normal Control
blood based biomarker compared normal control with IBD
Sponsors
Incheon St.Mary's Hospital
St Vincent's Hospital
Daejeon St. Mary's hospital
Bo-In Lee
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 2 | within 12 weeks of the blood sampling | hs-CRP (mg/dL) |
| measurement of blood-based biomarkers to predict disease activity 3 | within 12 weeks of the blood sampling | serum calprotectin (ng/mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Gender (M/F) | at the time of study enrolled | male of female |
| disease duration (months) | at the time of study enrolled | duration of disease |
Countries
South Korea
Contacts
Primary ContactBo-In Lee, MD. Ph.D.
Backup ContactSeungjun Kim, MD.
Outcome results
None listed