Clinical trial NCT06183697: Multi-omics Database Construction of Healthy Korean Volunteers
Official title: Clinical Study for Multi-omics Database Construction of a Cohort of Healthy Korean Volunteers for Integrative Microbiome Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Hanyang University Seoul Hospital
First posted: 2023-12-27
Enrollment: 3000
Sex: ALL
Minimum age (years): 13
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

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.


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.

Primary outcomes:
measure: Relative abundance of microbome
timeFrame: 5 years
measure: Alpha diversity of microbiome (Shannon diversity index)
timeFrame: 5 years
measure: Alpha diversity of microbiome (Fisher's index)
timeFrame: 5 years
measure: Alpha diversity of microbiome (Faith's phylogenetic diversity whole tree)
timeFrame: 5 years
Secondary outcomes:
measure: Gene count (transcriptomics)
timeFrame: 5 years
measure: Metabolite peak area (metabolomics)
timeFrame: 5 years
measure: Relative abundance (virome)
timeFrame: 5 years
measure: Number of differentially abundant bacterial strains isolated (culturomics)
timeFrame: 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
Study officials:
References: