NCT05107245已完成不适用
Observational Study on the Diagnostic Evaluation of the Intestinal Microbiota of French People Infected With the SARS-CoV-2.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 4
- 主要终点
- Alpha-diversity
研究概览
简要总结
In the context of the COVID-19 pandemic, the role of the gut microbiome is yet unknown. The aim of this trial is to evaluate the clinical contribution of the gut microbiome composition and diversity on the disease severity and to estimate the viral load in stool samples.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COVID-19 positive patients: hospitalised patients diagnosed with COVID-19 in one of the investigating sites, and able to provide a stool sample.
- •Control subjects: Medical and paramedical personnel working at one of the investigating sites, having been in direct contact with the patients.
- •Aged between 18 and 95 years.
- •Subjects able to read the French-language study information leaflet.
- •Patients with social cover.
排除标准
- •COVID-19 negative patients.
- •Patients in critical care, heart failure or respiratory failure.
- •Unable to provide naturally a stool sample.
- •Patients without social cover.
- •Pregnant women
结局指标
主要结局
Alpha-diversity
时间窗: at the time of inclusion in the study
Alpha-diversity of the gut microbiota measured by 16S sequencing
次要结局
- Microbiome composition(at the time of inclusion in the study)
- SARS-CoV-2 load(at the time of inclusion in the study)
研究者
研究点 (4)
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