Multi-omics Database Construction of Healthy Korean Volunteers

NCT06183697 | Recruiting

• 1 other identifier: MB-HV-01
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Relative abundance of microbome

  Analysis of the microbial community composition will be performed using 16s rRNA gene amplicon sequencing. The relative abundance of microbial species at the genus or family level will be assessed.

  5 years

• Alpha diversity of microbiome (Shannon diversity index)

  Alpha diversity will be measured using Shannon diversity index to combine ASV richness and abundance into a single evenness value

  5 years

• Alpha diversity of microbiome (Fisher's index)

  Alpha diversity will be measured using Fisher's index, which calculates the relationship between abundance and number

  5 years

• Alpha diversity of microbiome (Faith's phylogenetic diversity whole tree)

  Alpha diversity will be measured using Faith's phylogenetic diversity whole tree, representing the sum of all branch lengths as a measure of phylogeny and diversity.

  5 years

Secondary Outcomes (4)

• Gene count (transcriptomics)

  5 years

• Metabolite peak area (metabolomics)

  5 years

• Relative abundance (virome)

  5 years

• Number of differentially abundant bacterial strains isolated (culturomics)

  5 years

Eligibility Criteria

• Age: 13 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyunghee University Medical Center: lead
• Hanyang University Seoul Hospital: collaborator

Study Sites (1)

Kyung Hee University Hospital

Seoul, 02447, South Korea

RECRUITING

Related Publications (1)

• 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 DERIVED

Central Study Contacts

Bo-Hyung Kim, M.D., Ph.D.

CONTACT

+82-2-958-9765; bhkim98@khu.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 27, 2023
• Study Start: December 29, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)