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

December 20, 2021 updated by: Ilsoo Kim, MD, Yeouido St. Mary's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 07241
        • Recruiting
        • Yeouido St. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Ilsoo Kim, MD
        • Sub-Investigator:
          • Han Hee Lee, MD, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with the remission of disease activity.
Time Frame: 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).
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yeouido St. Mary's Hospital

Investigators

  • Principal Investigator: Ilsoo Kim, MD, Yeouido St. Mary's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 26, 2020

Primary Completion (ANTICIPATED)

May 31, 2025

Study Completion (ANTICIPATED)

August 25, 2025

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

December 20, 2021

First Posted (ACTUAL)

January 10, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 10, 2022

Last Update Submitted That Met QC Criteria

December 20, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC20TISI0103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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