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

NCT ID: NCT03778918

Last Updated: 2020-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-01

Study Completion Date

2020-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammatory Bowel Diseases Irritable Bowel Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

inflammatory bowel disease

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

inflammatory bowel disease

Intervention Type OTHER

blood based biomarkers in IBD such as REG3 alpha, serum calprotectin and hs-CRP

IBS or Normal Control

Intervention Type OTHER

blood based biomarker compared normal control with IBD

IBS or Normal Control

irritable bowel syndrome patients normal patients

inflammatory bowel disease

Intervention Type OTHER

blood based biomarkers in IBD such as REG3 alpha, serum calprotectin and hs-CRP

IBS or Normal Control

Intervention Type OTHER

blood based biomarker compared normal control with IBD

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

inflammatory bowel disease

blood based biomarkers in IBD such as REG3 alpha, serum calprotectin and hs-CRP

Intervention Type OTHER

IBS or Normal Control

blood based biomarker compared normal control with IBD

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Incheon St.Mary's Hospital

OTHER

Sponsor Role collaborator

St Vincent's Hospital

OTHER

Sponsor Role collaborator

Daejeon St. Mary's hospital

OTHER

Sponsor Role collaborator

Bo-In Lee

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bo-In Lee

Professor, MD, PhD.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bo-In Lee, MD. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Division of Gastroenterology; Seoul St. Mary's hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Bo-In Lee, MD. Ph.D.

Role: CONTACT

82-10-8367-1055

Seungjun Kim, MD.

Role: CONTACT

82-10-8786-2799

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Bo-In Lee, MD, PhD

Role: primary

82-10-8367-1055

References

Explore related publications, articles, or registry entries linked to this study.

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, Dore J, Brechot 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.

Reference Type BACKGROUND
PMID: 29133078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26278889 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23200544 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XC18TEDI0027

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Remote Monitoring of IBD
NCT05886322 UNKNOWN
Gene Expression in Inflammatory Bowel Disease
NCT01171872 ENROLLING_BY_INVITATION