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

Inflammatory Bowel Diseases Clinical Trial

Official title:

Development of the Cohort of the Patients With Inflammatory Bowel Disease in Yeouido St. Mary's Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05183256
• Other study ID #: SC20TISI0103
• Status: Recruiting
• Start date: October 26, 2020
• Est. completion date: August 25, 2025

Study information

• Verified date: December 2021
• Source: Yeouido St. Mary's Hospital
• Contact: Ilsoo Kim, MD
• Phone: 82237791517
• Email: ilsookim86[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 25, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
Korea, Republic of	Yeouido St. Mary's hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yeouido St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. Review. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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