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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 19 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03778918
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bo-In Lee
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bo-In Lee, MD. Ph.D.
Principal Investigator Affiliation Seoul St. Mary's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOther
Overall Status Recruiting
Countries Korea, Republic of
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Inflammatory Bowel Diseases, Irritable Bowel Syndrome
Additional Details

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.

Arms & Interventions

Arms

: inflammatory bowel disease

inflammatory bowel disease such as Ulcerative colitis and Crohn's disease

: IBS or Normal Control

irritable bowel syndrome patients normal patients

Interventions

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

Contact a Trial Team

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International Sites

Seoul, Korea, Republic of

Status

Recruiting

Address

Division of Gastroenterology; Seoul St. Mary's hospital

Seoul, , 137-701

Site Contact

Bo-In Lee, MD, PhD

gidoc4u@gmail.com

82-10-8367-1055

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