Multi-omics Database Construction of Healthy Korean Volunteers

Официальное название

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

Обзор

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.

Первичные конечные точки

• Relative abundance of microbome [Срок оценки: 5 years]
• Alpha diversity of microbiome (Shannon diversity index) [Срок оценки: 5 years]
• Alpha diversity of microbiome (Fisher's index) [Срок оценки: 5 years]
• Alpha diversity of microbiome (Faith's phylogenetic diversity whole tree) [Срок оценки: 5 years]

Вторичные конечные точки (4)

• Gene count (transcriptomics) [Срок оценки: 5 years]
• Metabolite peak area (metabolomics) [Срок оценки: 5 years]
• Relative abundance (virome) [Срок оценки: 5 years]
• Number of differentially abundant bacterial strains isolated (culturomics) [Срок оценки: 5 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 1 центр

• Kyung Hee University Hospital — Seoul

Публикации

• 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

Идентификаторы

NCT: NCT06183697 · MB-HV-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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