NCT06183697 Multi-omics Database Construction of Healthy Korean Volunteers
| NCT ID | NCT06183697 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kyunghee University Medical Center |
| Condition | Healthy |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2023-12-29 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2023-12-29 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this prospective, observational study is to collect health-related data including microbiome, blood samples, and dietary habits from the oral and gastrointestinal tracts in healthy subjects. In addition, the study aims to perform microbiome and multi-omics analysis on the collected samples and build an integrated database of the data.
Eligibility Criteria
Inclusion Criteria: * Subjects who are at least 13 years old and no older than 85 years old at the time of giving their informed consent. * Subjects who have received a comprehensive explanation of this study, fully understand it, and have voluntarily agreed to participate, providing signed and dated informed consent. * Subjects considered eligible for participation in the study by the researcher, based on screening procedures including physical examination, clinical laboratory tests, and questionnaires. Exclusion Criteria: * Subjects with a Body Mass Index (BMI) below 17.0 or above 30.0. * Vital signs at rest showing a systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg, along with symptoms related to high blood pressure such as headaches. * History of using specified drugs within a predetermined period before microbiome collection, as detailed in the Appendix. * Receipt of any vaccination within the last 4 weeks prior to microbiome collection. * Use of topical antibiotics or steroids on the face, scalp, neck, arms, forearms, or hands within 24 hours before microbiome collection. * Application of vaginal or vulvar medications, including antifungals, within 24 hours of microbiome collection. * Presence of an acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Sampling can be deferred until the subject recovers. * History of chronic, clinically significant disorders affecting the hepatic, digestive, circulatory, renal, neurological, respiratory, endocrine, immune, or hematological systems, as well as malignant tumors, psychiatric conditions, or substance abuse. * Substantial dietary alterations for rapid weight gain or loss within 4 weeks of the microbiome collection. * Positive serological tests (HBs antigen, HCV antibody, and HIV antibody tests) or results above the reference range. * History of gastrointestinal surgery, excluding simple procedures like appendectomy, cholecystectomy, or hernia repair. * Presence of gastrointestinal conditions that may influence microbiome analysis and are not under medical control, including Inflammatory Bowel Disease (IBD) including Crohn's disease and ulcerative colitis, Irritable Bowel Syndrome (IBS) requiring medication, ulcers, acute or chronic pancreatitis, and chronic constipation requiring medication. * Diagnosis of ankylosing spondylitis. * Requirement for the regular use of incontinence diapers. * Positive pregnancy test, or being pregnant or lactating. * Any medical condition suspected at the time of microbiome collection that may affect the integrity of the sample.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06183697 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 85 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06183697 currently recruiting?
Yes, NCT06183697 is actively recruiting participants. Contact the research team at bhkim98@khu.ac.kr for enrollment information.
Where is the NCT06183697 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06183697 clinical trial?
NCT06183697 is sponsored by Kyunghee University Medical Center. The trial plans to enroll 3,000 participants.