Omics-driven Research on the Gut-Oral Microbiome, Metabolome, Lifestyle, and Clinical Integration in Korean Inflammatory Bowel Disease

NCT06124833 | Recruiting DMC

• 1 other identifier: MB-IBD-01
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

The inflammatory bowel disease (IBD) is a condition that afflects approximately 5 million people worldwide, with 1.4 million in the US and 2.2 million in Europe. By 2030, it is predicted that up to 1% of the entire Western population will have this disease. Notably, IBD encompasses conditions like Crohn's disease (CD) and Ulcerative colitis (UC). The emergence of this disease in non-Western countries is attributed to the rapid urbanization and industrialization which has led to the adoption of Westernized diets, an increase in the use of antibiotics early in life, and air pollution. These factors are suspected to induce changes in the gut microbiome, contributing to the rise of IBD. However, as an immune-mediated chronic intestinal disease, it is a multifactorial condition triggered by genetic mutations, gut microbial features, and environmental factors. Despite numerous studies, the exact causes remain insufficiently understood, emphasizing the importance of research and development to significantly benefit the health of the rapidly increasing patients. The study aims to construct a multi-omics analysis platform, including gut microbiome analysis, using biosamples collected from Korean patients with inflammatory bowel disease (IBD) and their families. Through this platform, comparative clinical research will be conducted to elucidate the pathophysiology of the disease and develop potential biomarkers.

Conditions

Inflammatory Bowel Disease (IBD)

Keywords

Microbiota; Multiomics; Gut Microbiome; Oral Microbiome; Metabolome; Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Construction of a gut microbiome data platform by obtaining samples and clinical-related data from inflammatory bowel disease patients and control groups

  Verify the input of clinical information for collected microbiome data. Confirm the number of collected microbiome biospecimens. Verify whether the collected microbiome biospecimens align with the research proposal objectives. Ensure the production and management of microbiome data collected.

  5 years

Secondary Outcomes (1)

• Production and measurement of multi-omics data

  5 years

Study Arms (5)

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.

Disease Progression Cohort

Patients who were previously diagnosed with IBD and have been followed for over a year to understand disease progression and prognosis.

Drug Cohort

Patients with IBD who, during their tracking observations, begin using biological agents and small molecule drugs for the first time.

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).

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.

Eligibility Criteria

• Age: 13 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Approximately 900 patients with inflammatory bowel disease (IBD) and about 200 first-degree relatives of the patients.

You may qualify if:

• Korean patients with inflammatory bowel disease (including Crohn's disease and ulcerative colitis) aged between 13 and 85 years (at the time of participant consent).
• 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).
• 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.

You may not qualify if:

• For IBD patients
• \. Indeterminate colitis.
• For family control group
• 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.
• Individuals who have been vaccinated within the last month (4 weeks) prior to the microbiome collection date.
• 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.
• Individuals who have used vaginal/external genital medications, including antifungals, within 24 hours prior to the microbiome collection date.
• Individuals with acute conditions (e.g., moderate or severe diseases with or without fever; however, sample collection can be postponed until the participant recovers).
• 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.
• Individuals who have drastically changed their diet for rapid weight gain or loss within 4 weeks prior to the microbiome collection date.
• 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.
• Individuals requiring the use of incontinence diapers.
• Individuals with a positive urine pregnancy test, or who are pregnant or breastfeeding.
• Individuals suspected of having medical findings that may affect the sample collection at the time of microbiome sample collection.

Sponsors & Collaborators

• Chang Kyun Lee: lead
• Kangbuk Samsung Hospital: collaborator
• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: collaborator
• Inje University Haeundae Paik Hospital: collaborator
• Yeungnam University Hospital: collaborator
• Kyungpook National University Hospital: collaborator
• Chonnam National University Hospital: collaborator
• Wonkwang University Hospital: collaborator
• Daejeon St. Mary's hospital: collaborator
• Dankook University: collaborator
• Kyung Hee University Hospital at Gangdong: collaborator
• Inje University Ilsan Paik Hospital: collaborator
• Hanyang University Guri Hospital: collaborator
• Soon Chun Hyang University: collaborator
• Chung-Ang University Gwangmyeong Hospital: collaborator
• Keimyung University Dongsan Medical Center: collaborator

Study Sites (1)

Kyunghee University Medical Center

Seoul, 180-702, South Korea

RECRUITING

Related Publications (4)

• 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.

  PMID: 31142855 BACKGROUND

• 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.

  PMID: 24560869 BACKGROUND

• 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.

  PMID: 31142853 BACKGROUND

• 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.

  PMID: 40784769 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, tissue, stool, saliva, and DNA will be retained for central biobank

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Chang Kyun Lee, MD, PhD

  Kyunghee University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang Kyun Lee, MD, PhD

CONTACT

82-2-958-9996; changkyun.lee@khu.ac.kr

Shin Ju Oh, MD, PhD

CONTACT

82-2-958-9996; giosj204@gmail.com

Study Design

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

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 9, 2023
• Study Start: October 4, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)