Status:
RECRUITING
Omics-driven Research on the Gut-Oral Microbiome, Metabolome, Lifestyle, and Clinical Integration in Korean Inflammatory Bowel Disease
Lead Sponsor:
Chang Kyun Lee
Collaborating Sponsors:
Kangbuk Samsung Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Conditions:
Inflammatory Bowel Disease (IBD)
Eligibility:
All Genders
13-85 years
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%...
Detailed Description
This study aims to construct a multi-omics analysis platform using biosamples collected from patients with inflammatory bowel diseases (IBD) and their families. Through this platform, comparative clin...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- For IBD patients
- 1\. 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.
Key Trial Info
Start Date :
October 4 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT06124833
Start Date
October 4 2023
End Date
August 1 2028
Last Update
August 14 2025
Active Locations (1)
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1
Kyunghee University Medical Center
Seoul, South Korea, 180-702