Cohort of Inflammatory Bowel Disease Patient in Yeouido St. Mary's Hospital

NCT05183256 | Completed

• 1 other identifier: SC20TISI0103
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Pathologically Inflammatory bowel disease (IBD) is in chronic complex inflammatory gut pathological condition. Although the etiology of IBD is unknown, gut microbiota alteration (dysbiosis) is considered a novel factor involved in the pathogenesis of IBD. The aim of this study is to analyze gut microbiota in IBD patients.

Conditions

Inflammatory Bowel Diseases

Keywords

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Number of participants with the remission of disease activity.

  Disease activity is assessed in a clinical, endoscopic, and biochemical way. Each activity is determined by the Mayo score (in UC), Crohn's Disease Activity Index (in CD), Ulcerative Colitis Endoscopic Index of Severity (in UC), Simple Endoscopic Score for Crohn Disease (in CD), and biochemical findings (e.g. fecal calprotectin).

  through study completion, an average of 2 year

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients with IBD, presented to division of gastroenterology, Yeouido St.Mary's hospital, will be asked to participate in this study.

You may qualify if:

• The below 3 conditions must be met simultaneously.
• Patient who can voluntarily consent to this study.
• Patient who has inflammatory bowel disease.
• Patient who is aged less than 75 years.

You may not qualify if:

• a patient meets any of the below conditions.
• If a patient has an IBD other than UC and CD.
• If a patient is vulnerable due to his/her position as an employee of Yeouido St.Mary's hospital or a medical student of the Catholic University of Korea.
• If a patient is pregnant.
• Foreign personal who cannot speak Korean.

Sponsors & Collaborators

• Yeouido St. Mary's Hospital: lead

Study Sites (1)

Yeouido St. Mary's hospital

Seoul, 07241, South Korea

Location

Related Publications (2)

• Park SH, Kim YJ, Rhee KH, Kim YH, Hong SN, Kim KH, Seo SI, Cha JM, Park SY, Jeong SK, Lee JH, Park H, Kim JS, Im JP, Yoon H, Kim SH, Jang J, Kim JH, Suh SO, Kim YK, Ye BD, Yang SK; Songpa-Kangdong Inflammatory Bowel Disease [SK-IBD] Study Group. A 30-year Trend Analysis in the Epidemiology of Inflammatory Bowel Disease in the Songpa-Kangdong District of Seoul, Korea in 1986-2015. J Crohns Colitis. 2019 Oct 28;13(11):1410-1417. doi: 10.1093/ecco-jcc/jjz081.

  PMID: 30989166 RESULT

• Dalal SR, Chang EB. The microbial basis of inflammatory bowel diseases. J Clin Invest. 2014 Oct;124(10):4190-6. doi: 10.1172/JCI72330. Epub 2014 Aug 1.

  PMID: 25083986 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples are collected to assess the severity of IBD. Tissue samples through colonoscopy biopsy and stool samples are collected to find out gut flora through DNA analysis. No human DNA analysis is targeted.

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Ilsoo Kim, MD

  Yeouido St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 10, 2022
• Study Start: October 26, 2020
• Primary Completion: June 30, 2023
• Study Completion: July 24, 2023
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)