Building a health data database from healthy Korean volunteers

Clinical Study for Multi-omics Database Construction of a Cohort of Healthy Korean Volunteers for Integrative Microbiome Analysis

This study is collecting health information and samples from healthy Korean volunteers aged 13 to 85 to better understand their health and create a detailed database.

Quick facts

• Study type: Observational
• Enrollment: 3000 (estimated)
• Ages: 13 Years to 85 Years
• Sex: All
• Sponsor: Kyunghee University Medical Center (Academic / other)
• Locations: 1 site (Seoul)
• Trial ID: NCT06183697 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect health-related data from healthy individuals, including microbiome samples, blood samples, and dietary habits. Participants aged 13 to 85 will undergo screening procedures to ensure eligibility, and their data will be analyzed to create a comprehensive multi-omics database. The study focuses on understanding the health profiles of the Korean population through integrated data analysis.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy individuals aged between 13 and 85 who meet specific health criteria.

Not a fit: Patients with significant health issues, such as high blood pressure or those outside the specified BMI range, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the health profiles of healthy individuals, potentially guiding future health recommendations and interventions.

How similar studies have performed: While similar multi-omics studies have been conducted, this specific approach focusing on healthy Korean volunteers is relatively novel.

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.

Where this trial is running

Seoul

• Kyung Hee University Hospital — Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: Bo-Hyung Kim, M.D., Ph.D.

Conditions Healthy