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OpenTrials
Completed

NCT Number: NCT05183256

Cohort of Inflammatory Bowel Disease Patient 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.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yeouido St. Mary's hospital

Seoul, 07241, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Yeouido St. Mary's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2022
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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