IBD (general)Recruiting
Omics-driven Research on the Gut-Oral Microbiome, Metabolome, Lifestyle, and Clinical Integration in Korean Inflammatory Bowel Disease
Observational · No treatment assigned · 1 site · Chang Kyun Lee
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Disease (IBD). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 13 to 85
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 14 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 900 participants are expected to take part.
- Start date: 2023-10-04.
- Main results expected around 2028-08-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in South Korea.
Main thing being measured
- Construction of a gut microbiome data platform by obtaining samples and clinical-related data from inflammatory bowel disease patients and control groups (5 years)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Disease (IBD) |
| Lead sponsor | Chang Kyun Lee |
| Collaborators | Kangbuk Samsung Hospital; Chung-Ang University Hospital; Inje University Haeundae Paik Hospital; Yeungnam University Hospital; Kyungpook National University Hospital; Chonnam National University Hospital; Wonkwang University Hospital; Daejeon St. Mary's hospital; Dankook University; Kyung Hee University Hospital at Gangdong; Inje University Ilsan Paik Hospital; Hanyang University Guri Hospital; Soon Chun Hyang University; Chung-Ang University Gwangmyeong Hospital; Keimyung University Dongsan Medical Center |
| Enrollment | 900 (estimated) |
| Start date | 2023-10-04 |
| Primary completion (est.) | 2028-08-01 |
| First posted | 2023-11-09 |
| Last updated | 2025-08-14 |
| Official title | Building an Integrated Gut Microbiome Data Analysis Platform and Conducting Comparative Clinical Studies in Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT06124833 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: 1. 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). 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: * For IBD patients 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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Kyunghee University Medical Center | Seoul | South Korea | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.