NCT07011979

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2022

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 10, 2025

Status Verified

April 1, 2025

Enrollment Period

4 years

First QC Date

June 2, 2025

Last Update Submit

June 2, 2025

Conditions

Keywords

Crohn DiseaseUlcerative ColitisPsoriasisAnkylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

  • Incidence of Inflammatory Bowel Disease

    Up to 20 years from enrollment

Eligibility Criteria

Age10 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of individuals at high risk for Inflammatory Bowel Disease (IBD), including: (1) first-degree relatives of IBD patients who routinely visit the outpatient clinics; (2) individuals with a confirmed positive serum ASCA result identified in the outpatient clinics; and (3) patients with autoimmune diseases who are regularly followed at outpatient clinics. Participants will be recruited from Seoul National University Hospital, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, and Seoul National University Hospital Healthcare System Gangnam Center.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, UlcerativePsoriasisSpondylitis, Ankylosing

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic DiseasesSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesAxial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 2, 2025

First Posted

June 10, 2025

Study Start

January 7, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

June 10, 2025

Record last verified: 2025-04

Locations