Inflammatory Bowel Disease (IBD)SNU PREVENTNCT07011979
SNU IBD Cohort Study : Searching for Characterization of High Risk Populations for Developing Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease (IBD), run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jan 2022to 31 Dec 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- first-degree relatives of Inflammatory Bowel Disease patients
- patients who are diagnosed with autoimmune diseases
- patients with functional gastrointestinal disorders who are ASCA-positive
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Koh, 82027408112, jel1206@snu.ac.kr
About this study
Official title: SNU IBD Cohort Study : Searching for Characterization of High Risk Populations for Developing Inflammatory Bowel Disease (SNU PREVENT)
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:
Read more
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.
Read the 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)
- Keywords
- Crohn Disease, Ulcerative Colitis, Psoriasis, Ankylosing Spondylitis
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Psoriasis, Spondylitis, Ankylosing
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Inflammatory Bowel Disease
Measured: Up to 20 years from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start7 Jan 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SeongJoon Koh, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011979
- Sponsor's protocol ID
- H-2110-155-1266
- Acronym
- SNU PREVENT
- Status last verified
- Apr 2025
- First submitted
- 2 Jun 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SNU IBD Cohort Study : Searching for Characterization of High Risk Populations for Developing Inflammatory Bowel Disease (SNU PREVENT)
- ClinicalTrials.gov ID
- NCT07011979
- Acronym / sponsor ID
- SNU PREVENT / H-2110-155-1266
- Conditions
- Inflammatory Bowel Disease (IBD)
- Keywords
- Crohn Disease, Ulcerative Colitis, Psoriasis, Ankylosing Spondylitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- first-degree relatives of Inflammatory Bowel Disease patients
- patients who are diagnosed with autoimmune diseases
- patients with functional gastrointestinal disorders who are ASCA-positive
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Inflammatory Bowel Disease
Time frame: Up to 20 years from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (IBD), run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Inflammatory Bowel Disease (time frame: Up to 20 years from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.