HealthyNCT06183697
Multi-omics Database Construction of Healthy Korean Volunteers
An observational study of Healthy, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Dec 2023to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee University Hospital
Seoul, 02447
Bo-Hyung Kim, MD, PhD, 82-2-958-9326, bhkim98@khu.ac.kr
About this study
Official title: Clinical Study for Multi-omics Database Construction of a Cohort of Healthy Korean Volunteers for Integrative Microbiome Analysis
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 5 years
Secondary outcomes (4)
Gene count (transcriptomics)
Analysis of bacterial mRNA profiles will be performed through read mapping using NCBI RefSeq database, quantification of gene and transcript \& bacterial taxonomic profiling using HUMAnN and MetaPhlAn pipeline, transcript quantification and identification of differentially expressed gene using SALMON and human reference genome fastq file.
Measured: 5 years
Metabolite peak area (metabolomics)
Analysis of metabolites will be performed by matching metabolite ID achieved from LC/MS with Human Metabolome Database (HMDB) for metabolite identification. Analysis on the difference of metabolite between groups will be performed by PCA or PLS-DA using MZmine3, OpenChrome or Metaboanalyst v5.0.
Measured: 5 years
Relative abundance (virome)
Analysis of total virus profiles will be performed by comparing viral protein sequence with NCBI refseq viral database and taxonomy annotation.
Measured: 5 years
Number of differentially abundant bacterial strains isolated (culturomics)
Bacterial strains that exhibit differential abundance between healthy individuals and patients will be inoculated, isolated, and identified.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start29 Dec 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hanyang University Seoul Hospital
- Responsible party
- Principal investigator, BoHyung Kim, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183697
- Sponsor's protocol ID
- MB-HV-01
- Status last verified
- Mar 2025
- First submitted
- 23 Nov 2023
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40784769
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for Multi-omics Database Construction of a Cohort of Healthy Korean Volunteers for Integrative Microbiome Analysis
- ClinicalTrials.gov ID
- NCT06183697
- Acronym / sponsor ID
- MB-HV-01
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Collaborators
- Hanyang University Seoul Hospital
- Study start
- 29 Dec 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relative abundance of microbome
Time frame: 5 years
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.
Alpha diversity of microbiome (Shannon diversity index)
Time frame: 5 years
Alpha diversity will be measured using Shannon diversity index to combine ASV richness and abundance into a single evenness value
Alpha diversity of microbiome (Fisher's index)
Time frame: 5 years
Alpha diversity will be measured using Fisher's index, which calculates the relationship between abundance and number
Alpha diversity of microbiome (Faith's phylogenetic diversity whole tree)
Time frame: 5 years
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Derived from this study: PubMed 40784769Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Kyunghee University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo-Hyung Kim, M.D., Ph.D. (+82-2-958-9765, bhkim98@khu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative abundance of microbome (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06183697, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.