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

Completed

• Conditions: Inflammatory Bowel Diseases

• Registration Number: NCT05183256
• Lead Sponsor: Yeouido St. Mary's Hospital

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.

Detailed Description

Inflammatory bowel disease (IBD) (Crohn's disease (CD) and ulcerative colitis (UC)) occurs worldwide with differences in epidemiology, etiology, and phenotype between regions. 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 DNA of microbiota will be investigated with samples of stool, colon tissue. The aim is to establish a cohort group for IBD (1), to make a database on cohort group characteristics such as endoscopic findings, disease severity, epidemiology, and prognosis (2), to analyze gut flora in IBD patients (3).

Study Timeline

• Study Start: 2020-10-26
• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-20
• Study First Posted: 2022-01-10
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• The below 3 conditions must be met simultaneously.

  1. Patient who can voluntarily consent to this study.
  2. Patient who has inflammatory bowel disease.
  3. Patient who is aged less than 75 years.

Exclusion Criteria

• a patient meets any of the below conditions.

  1. If a patient has an IBD other than UC and CD.
  2. 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.
  3. If a patient is pregnant.
  4. Foreign personal who cannot speak Korean.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with the remission of disease activity.	through study completion, an average of 2 year	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).

Trial Locations

Locations (1)

Yeouido St. Mary's hospital; 🇰🇷 Seoul, Korea, Republic of