Omics-driven Research on the Gut-Oral Microbiome, Metabolome, Lifestyle, and Clinical Integration in Korean Inflammatory Bowel Disease
NCT ID: NCT06124833
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
900 participants
OBSERVATIONAL
2023-10-04
2028-08-01
Brief Summary
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Detailed Description
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1. To identify clinical risk factors, genotype-genome variations, microbiome, and metabolomic markers that can predict high-risk groups prone to poor therapeutic outcomes and complications.
2. To elucidate differences in genotype, gut microbiome distribution, and metabolomics between non-responders to biological agents and small molecule drugs versus those with good therapeutic responses. Using this information, the aim is to develop multi-omics biomarkers that can predict responders and non-responders.
3. To develop a multi-omics biomarker-based algorithm that can prioritize the choice of various biological agents or small molecule drugs for individual patients.
4. To construct guidelines for precision treatment by identifying multi-omics markers associated with the onset of IBD, disease exacerbation, and complications and by clarifying the role of multi-omics in the pathophysiological mechanism.
5. Using familial IBD patients and family control groups, the study aims to elucidate environmental and genetic factors associated with the onset of IBD.
6. By comparing with the data of healthy intestines (non-blood-related disease control group), the role of gut microbiota in the pathogenesis of IBD and associated diseases in Koreans will be clarified.
7. By comparing with data from other target disease patients (e.g., AS, HIV), the role of gut microbiota in the onset of immune-mediated inflammatory diseases and associated conditions will be elucidated.
8. An integrated analysis of prior genomic data, current project genomic data (from the gut, oral-respiratory, skin, urogenital tracts), other domestic and international cohorts, and overseas genomic data will clarify regional and ethnic differences and roles of gut microbiota in the pathogenesis of IBD and associated diseases in Koreans.
9. To elucidate the interrelationship between human host genetic traits, microbiome, and environmental influences in the pathogenesis of IBD.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Newly Diagnosed Cohort
Patients who have been diagnosed with inflammatory bowel disease (IBD, including Crohn's disease and ulcerative colitis) for the first time within the last 6 months prior to study enrollment.
No interventions assigned to this group
Disease Progression Cohort
Patients who were previously diagnosed with IBD and have been followed for over a year to understand disease progression and prognosis.
No interventions assigned to this group
Drug Cohort
Patients with IBD who, during their tracking observations, begin using biological agents and small molecule drugs for the first time.
No interventions assigned to this group
Familial IBD cohort
Cases where there are 2 or more diagnosed IBD patients among the patient's first-degree relatives (≥ 2 IBD-affected First Degree Relatives, FDR).
No interventions assigned to this group
Family Control Group
First-degree blood relatives of the patient who have never been diagnosed with IBD up to the point of study enrollment and who reside with the patient.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. First-degree blood relatives of the patient, aged between 13 and 85, who have never been diagnosed with IBD and reside with the patient (Family Control Group).
3. Participants who have received a detailed explanation about this clinical trial, fully understand it, have voluntarily decided to participate, and have given written consent to comply with the precautions.
Exclusion Criteria
1\. Indeterminate colitis.
* For family control group
1. Individuals with a history of using medications listed in Appendix 13 (Family Control Group Medication History) within a pre-specified period before the microbiome collection date.
2. Individuals who have been vaccinated within the last month (4 weeks) prior to the microbiome collection date.
3. Individuals who have applied topical antibiotics or topical steroids to the face, scalp, neck, or arms, forearms, hands within 24 hours prior to the microbiome collection date.
4. Individuals who have used vaginal/external genital medications, including antifungals, within 24 hours prior to the microbiome collection date.
5. Individuals with acute conditions (e.g., moderate or severe diseases with or without fever; however, sample collection can be postponed until the participant recovers).
6. Individuals with chronic and clinically significant histories of liver, digestive, cardiovascular, renal, neurological, respiratory, endocrine, immune, hematological disorders, malignancies, psychiatric conditions, or a history of drug abuse.
7. Individuals who have drastically changed their diet for rapid weight gain or loss within 4 weeks prior to the microbiome collection date.
8. Individuals with gastrointestinal disorders that could impact microbiome analysis and are not currently medically managed or individuals under treatment for the following conditions: Inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis), Irritable bowel syndrome (requiring drug therapy), Ulcers, acute or chronic pancreatitis, etc.
9. Individuals requiring the use of incontinence diapers.
10. Individuals with a positive urine pregnancy test, or who are pregnant or breastfeeding.
11. Individuals suspected of having medical findings that may affect the sample collection at the time of microbiome sample collection.
13 Years
85 Years
ALL
No
Sponsors
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Kangbuk Samsung Hospital
OTHER
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
OTHER
Inje University Haeundae Paik Hospital
OTHER
Yeungnam University Hospital
OTHER
Kyungpook National University Hospital
OTHER
Chonnam National University Hospital
OTHER
Wonkwang University Hospital
OTHER
Daejeon St. Mary's hospital
OTHER
Dankook University
OTHER
Kyung Hee University Hospital at Gangdong
OTHER
Inje University Ilsan Paik Hospital
OTHER
Hanyang University
OTHER
Soon Chun Hyang University
OTHER
Chung-Ang University Gwangmyeong Hospital
OTHER
Keimyung University Dongsan Medical Center
OTHER
Chang Kyun Lee
OTHER
Responsible Party
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Chang Kyun Lee
Professor
Principal Investigators
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Chang Kyun Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kyunghee University Medical Center
Locations
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Kyunghee University Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Lloyd-Price J, Arze C, Ananthakrishnan AN, Schirmer M, Avila-Pacheco J, Poon TW, Andrews E, Ajami NJ, Bonham KS, Brislawn CJ, Casero D, Courtney H, Gonzalez A, Graeber TG, Hall AB, Lake K, Landers CJ, Mallick H, Plichta DR, Prasad M, Rahnavard G, Sauk J, Shungin D, Vazquez-Baeza Y, White RA 3rd; IBDMDB Investigators; Braun J, Denson LA, Jansson JK, Knight R, Kugathasan S, McGovern DPB, Petrosino JF, Stappenbeck TS, Winter HS, Clish CB, Franzosa EA, Vlamakis H, Xavier RJ, Huttenhower C. Multi-omics of the gut microbial ecosystem in inflammatory bowel diseases. Nature. 2019 May;569(7758):655-662. doi: 10.1038/s41586-019-1237-9. Epub 2019 May 29.
Kostic AD, Xavier RJ, Gevers D. The microbiome in inflammatory bowel disease: current status and the future ahead. Gastroenterology. 2014 May;146(6):1489-99. doi: 10.1053/j.gastro.2014.02.009. Epub 2014 Feb 19.
Integrative HMP (iHMP) Research Network Consortium. The Integrative Human Microbiome Project. Nature. 2019 May;569(7758):641-648. doi: 10.1038/s41586-019-1238-8. Epub 2019 May 29.
Kim HS, Kim BH, Nam B, Oh SJ, Park SK, Lee SW, Lee JY, Jo S, Lee YA, Lee JY, Park DI, Kim TH, Lee CK. Oral-gut microbiome axis in a Korean cohort with inflammatory bowel disease and ankylosing spondylitis (INTEGRATE): a prospective and observational study protocol. BMJ Open. 2025 Aug 10;15(8):e092075. doi: 10.1136/bmjopen-2024-092075.
Other Identifiers
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MB-IBD-01
Identifier Type: -
Identifier Source: org_study_id
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