Clinical trial NCT05183256: Cohort of Inflammatory Bowel Disease Patient in Yeouido St. Mary's Hospital
Official title: Development of the Cohort of the Patients With Inflammatory Bowel Disease in Yeouido St. Mary's Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Keywords: Inflammatory Bowel Disease
Lead sponsor: Yeouido St. Mary's Hospital
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 28
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with the remission of disease activity.
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yeouido St. Mary's hospital
Study officials:
affiliation: Yeouido St. Mary's Hospital
name: Ilsoo Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
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 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.
citation: 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.