Multi-omics Database Construction of Healthy Korean Volunteers
Recruiting
Observational Study
Healthy
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
13 – 85
Sex
Any
Study type
Observational
Participants needed
3,000 (estimated)
Sponsor
Kyunghee University Medical Center · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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 dat…
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.
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