A Non-Interventional Pilot Study to Explore the Role of Gut Flora in COVID-19 Infection
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
研究概览
简要总结
This study seeks to determine whether the virus which causes COVID-19, SARS-CoV-2, is shed in the stools of patients who are infected.
详细描述
In this study the stool of patients who are being treated for COVID-19 will be tested during treatment and then again following treatment to determine if the virus is shed in the stool during infection, afterwards, or both.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
- •Male or female of 18 years of age or older
- •Diagnosis of COVID-19 infection by RT- PCR within 1 week of Screening
排除标准
- •Refusal to sign informed consent form
- •History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
- •Postoperative stoma, ostomy, or ileoanal pouch
- •Treatment with total parenteral nutrition
研究组 & 干预措施
General Population
The general population will have their microbiome sequenced from stool samples provided.
干预措施: There is no intervention in this study (Other)
结局指标
主要结局
Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
时间窗: One year
Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific gastrointestinal disease types.
次要结局
- Validation of Sequencing Methods(One year)