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Recruiting NCT06183697

Multi-omics Database Construction of Healthy Korean Volunteers

— Observational Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 13 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Relative abundance of microbome [Time frame: 5 years]
  • Alpha diversity of microbiome (Shannon diversity index) [Time frame: 5 years]
  • Alpha diversity of microbiome (Fisher's index) [Time frame: 5 years]
  • Alpha diversity of microbiome (Faith's phylogenetic diversity whole tree) [Time frame: 5 years]
Secondary outcome measures (4)
  • Gene count (transcriptomics) [Time frame: 5 years]
  • Metabolite peak area (metabolomics) [Time frame: 5 years]
  • Relative abundance (virome) [Time frame: 5 years]
  • Number of differentially abundant bacterial strains isolated (culturomics) [Time frame: 5 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Kyung Hee University Hospital — Seoul

Publications

  • Kim HS, Kim BH, Nam B, Oh SJ, Park SK, Lee SW, Lee JY, Jo S, Lee YA, Lee JY, Park DI, Kim TH, Lee CK. Oral-gut microbiome axis in a Korean cohort with inflammatory bowel disease and ankylosing spondylitis (INTEGRATE): a prospective and observational study protocol. BMJ Open. 2025 Aug 10;15(8):e092075. doi: 10.1136/bmjopen-2024-092075. PMID 40784769

Identifiers

NCT: NCT06183697 · MB-HV-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗