Clinical Study for Multi-omics Database Construction of a Cohort of Healthy Korean Volunteers for Integrative Microbiome Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Alpha diversity of microbiome (Faith's phylogenetic diversity whole tree)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Subjects with a Body Mass Index (BMI) below 17.0 or above 30.
- •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.
结局指标
主要结局
Alpha diversity of microbiome (Faith's phylogenetic diversity whole tree)
时间窗: 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.
Relative abundance of microbome
时间窗: 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)
时间窗: 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)
时间窗: 5 years
Alpha diversity will be measured using Fisher's index, which calculates the relationship between abundance and number
次要结局
- Gene count (transcriptomics)(5 years)
- Relative abundance (virome)(5 years)
- Number of differentially abundant bacterial strains isolated (culturomics)(5 years)
- Metabolite peak area (metabolomics)(5 years)
研究者
BoHyung Kim
Professor
Kyunghee University Medical Center