Genome-based Multiomics Analysis on Gut Microbiome in People Living With HIV and HBV
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Collect clinical information data and stool from HIV and HBV patients
研究概览
简要总结
Building a Microbiome Data Platform and Conducting Clinical Evidence Research in Individuals Infected with the Human Immunodeficiency Virus (HIV) and Hepatitis B virus.
详细描述
Chronic HIV infection, which often results in metabolic disorders, leads to shifts in the gut microbiota, contributing to immune activation and chronic inflammation. This study seeks to compare the gut microbiota in individuals with chronic HIV infection and chronic hepatitis B patients. The objective is to identify specific gut bacterial strains and metabolic pathways linked to the metabolic disorders commonly observed in HIV patients.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV patients
- •Inidividuals over 19 years old
- •HIV patients on antiretroviral therapy (ART)
- •HBV patients
- •Individuals over 19 years old
- •Chronic hepatitis B patients with either chronic hepatitis, liver cirrhosis or hepatocellular carcinoma
排除标准
- •Patients with indeterminate colitis
- •Individuals who have used antibiotics or steroids within 24 hours of the microbiome sample collection (excluding antiviral treatments for hepatitis B and HIV)
- •Individuals who have used vaginal or external medications, including antifungal agents, within 24 hours of microbiome sample collection
- •Those with acute illnesses, with or without fever, of moderate or severe severity; however, sampling may be postponed until the subject recovers.
- •Individuals with gastrointestinal disorders that may impact microbiome analysis and are currently medically uncontrolled or under treatment for the respective condition
- •Individuals with a positive result in a urine pregnancy test, pregnant, or breastfeeding at the time of microbiome sample collection
- •Individuals for whom medical opinions suspect that they may have an impact on the sample collection at the time of microbiome collection.
结局指标
主要结局
Collect clinical information data and stool from HIV and HBV patients
时间窗: 2 years
Clinical information data will be collected from both HIV and HBV infected patients. Biosamples collected from these individuals will be used to establish a multi-omics analysis platform, including the examination of the intestinal microbiome. With this platform, comparative clinical studies will be conducted to uncover the disease's pathophysiology and identify potential biomarkers related to metabolic diseases.
次要结局
- Shotgun metagenomic sequencing will be done with stool collected from HIV and HBV patients(2 years)
研究者
Eun-Jeong Joo
M.D, Ph.D
Kangbuk Samsung Hospital