SNU IBD Cohort Study : Searching for Characterization of High Risk Populations for Developing Inflammatory Bowel Disease

NCT ID: NCT07011979

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-07
• Study Completion Date: 2025-12-31

Brief Summary

The goal of this observational study is to investigate characteristics of individuals at high risk for developing Inflammatory Bowel Disease (IBD) in order to identify risk factors associated with its incidence.

The main question it aims to answer is:

What are the risk factors for developing Inflammatory Bowel Disease?

Researchers will compare groups at high risk for IBD to healthy populations and to patients already diagnosed with IBD.

Participants will

• undergo assessments of general demographic and clinical characteristics.
• be monitored for symptoms using questionnaires administered at regular intervals.
• have blood tests and stool examinations performed. In cases where participants undergo colonoscopy for routine clinical indications, gut biopsies will also be performed.

Detailed Description

Recruitment announcements for participants who are first-degree relatives with patients of IBD will be posted on the bulletin board of the patient community, the outpatient bulletin board, and in the consultation room. For patients with confirmed Anti-Saccharomyces cerevisiae antibody (ASCA) positivity or those diagnosed with autoimmune diseases, recruitment will be conducted from among outpatients who meet the criteria. Detailed explanations about the study will be provided, and consent to participate will be obtained prior to recruitment.

Blood and stools will be used for genomic and proteomic, metabolomic analysis. 16s rRNA gene sequencing and whole genome shotgun sequencing will be done for microbiome analysis. Biopsy specimen will be used for proteomic analysis.

Adverse events related with blood sampling will be monitored in outpatient clinic.

Conditions

Inflammatory Bowel Disease (IBD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• first-degree relatives of Inflammatory Bowel Disease patients
• patients who are diagnosed with autoimmune diseases
• patients with functional gastrointestinal disorders who are ASCA-positive

Exclusion Criteria

• Patients with symptoms such as a 10% weight loss within 3 months, abdominal pain, hematochezia, or diarrhea will undergo colonoscopy, and those diagnosed with Inflammatory Bowel Disease will be excluded.
• Treatment history of Diabetes Mellitus, Irritable Bowel Syndrome, or colon cancer.

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

SeongJoon Koh

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Koh

Role: primary

jel1206@snu.ac.kr

82027408112

Other Identifiers

H-2110-155-1266

Identifier Type: -

Identifier Source: org_study_id