Actively Recruiting
Omics-driven Research on the Gut-Oral Microbiome, Metabolome, Lifestyle, and Clinical Integration in Korean Inflammatory Bowel Disease
Led by Chang Kyun Lee · Updated on 2025-08-14
900
Participants Needed
1
Research Sites
251 weeks
Total Duration
On this page
Sponsors
C
Chang Kyun Lee
Lead Sponsor
K
Kangbuk Samsung Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Omics-driven Research on the Gut-Oral Microbiome, Metabolome, Lifestyle, and Clinical Integration in Korean Inflammatory Bowel Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- For IBD patients: Indeterminate colitis.
- For family control group: History of using specified medications within a set period before microbiome collection.
- Vaccinated within the last 4 weeks before microbiome collection.
- Applied topical antibiotics or steroids to face, scalp, neck, arms, forearms, hands within 24 hours before microbiome collection.
- Used vaginal or external genital medications, including antifungals, within 24 hours before microbiome collection.
- Acute moderate or severe illnesses (sample collection can be postponed until recovery).
- Chronic and clinically significant liver, digestive, cardiovascular, renal, neurological, respiratory, endocrine, immune, hematological disorders, malignancies, psychiatric conditions, or history of drug abuse.
- Recent drastic diet changes for rapid weight gain or loss within 4 weeks before microbiome collection.
- Gastrointestinal disorders impacting microbiome analysis not currently medically managed or under treatment for IBD, irritable bowel syndrome needing drug therapy, ulcers, pancreatitis, etc.
- Requires use of incontinence diapers.
- Positive urine pregnancy test, pregnant, or breastfeeding.
- Medical findings suspected to affect sample collection at time of microbiome collection.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kyunghee University Medical Center
Seoul, South Korea, 180-702
Actively Recruiting
Research Team
C
Chang Kyun Lee, MD, PhD
CONTACT
S
Shin Ju Oh, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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