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

Inflammatory Bowel Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03778918
• Other study ID #: XC18TEDI0027
• Status: Recruiting
• Start date: August 1, 2016
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2020
• Source: Seoul St. Mary's Hospital
• Contact: Bo-In Lee, MD. Ph.D.
• Phone: 82-10-8367-1055
• Email: gidoc4u[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Irritable Bowel Syndrome

Intervention

Other:
• inflammatory bowel disease
blood based biomarkers in IBD such as REG3 alpha, serum calprotectin and hs-CRP
• IBS or Normal Control
blood based biomarker compared normal control with IBD

Locations

Country	Name	City	State
Korea, Republic of	Division of Gastroenterology; Seoul St. Mary's hospital	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Bo-In Lee	Daejeon St. Mary's hospital, Incheon St.Mary's Hospital, St. Vincent's Hospital-Manhattan

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Darnaud M, Dos Santos A, Gonzalez P, Augui S, Lacoste C, Desterke C, De Hertogh G, Valentino E, Braun E, Zheng J, Boisgard R, Neut C, Dubuquoy L, Chiappini F, Samuel D, Lepage P, Guerrieri F, Doré J, Bréchot C, Moniaux N, Faivre J. Enteric Delivery of Regenerating Family Member 3 alpha Alters the Intestinal Microbiota and Controls Inflammation in Mice With Colitis. Gastroenterology. 2018 Mar;154(4):1009-1023.e14. doi: 10.1053/j.gastro.2017.11.003. Epub 2017 Nov 11. — View Citation

Greuter T, Lang S, Holler E, Hawkey CJ, Rogler G, Biedermann L; ASTIC trial group. Serum REG3alpha and C-Reactive Protein Levels in Crohn's Disease Patients Undergoing Immunoablation and Autologous Hemopoetic Stem Cell Transplantation in the ASTIC Trial. Digestion. 2015;92(2):83-9. doi: 10.1159/000437300. Epub 2015 Aug 1. — View Citation

Harris AC, Levine JE, Ferrara JL. Have we made progress in the treatment of GVHD? Best Pract Res Clin Haematol. 2012 Dec;25(4):473-8. doi: 10.1016/j.beha.2012.10.010. Epub 2012 Oct 25. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of blood-based biomarkers to predict disease activity 1	REG3 alpha (ng/mL)	within 12 weeks of the blood sampling
Primary	measurement of blood-based biomarkers to predict disease activity 2	hs-CRP (mg/dL)	within 12 weeks of the blood sampling
Primary	measurement of blood-based biomarkers to predict disease activity 3	serum calprotectin (ng/mL)	within 12 weeks of the blood sampling
Secondary	Age (years)	age at the time of study enrolled	at the time of study enrolled
Secondary	Gender (M/F)	male of female	at the time of study enrolled
Secondary	disease duration (months)	duration of disease	at the time of study enrolled
Secondary	disease onset (years)	age at which the disease begins	at the time of study enrolled