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

Study Overview
=================
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.

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

Conditions
-----------------
Inflammatory Bowel Diseases, Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Other: inflammatory bowel disease
* Other: IBS or Normal Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| inflammatory bowel disease<br>inflammatory bowel disease such as Ulcerative colitis and Crohn's disease | Other: inflammatory bowel disease<br>* blood based biomarkers in IBD such as REG3 alpha, serum calprotectin and hs-CRP<br>Other: IBS or Normal Control<br>* blood based biomarker compared normal control with IBD<br>|
| IBS or Normal Control<br>irritable bowel syndrome patients normal patients | Other: inflammatory bowel disease<br>* blood based biomarkers in IBD such as REG3 alpha, serum calprotectin and hs-CRP<br>Other: IBS or Normal Control<br>* blood based biomarker compared normal control with IBD<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of blood-based biomarkers to predict disease activity 1 | REG3 alpha (ng/mL) | within 12 weeks of the blood sampling | 
| measurement of blood-based biomarkers to predict disease activity 2 | hs-CRP (mg/dL) | within 12 weeks of the blood sampling | 
| measurement of blood-based biomarkers to predict disease activity 3 | serum calprotectin (ng/mL) | within 12 weeks of the blood sampling | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age (years) | age at the time of study enrolled | at the time of study enrolled | 
| Gender (M/F) | male of female | at the time of study enrolled | 
| disease duration (months) | duration of disease | at the time of study enrolled | 
| disease onset (years) | age at which the disease begins | at the time of study enrolled | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
REG3 alpha, IBD, biomarker, ulcerative colitis, serum calprotectin