DETERMINING THE IMPACT OF MICROBIAL DYSBIOSIS ON IMMUNE AND BARRIER DYSFUNCTION IN LONG COVID
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- To determine whether people with long COVID exhibit microbial dysbiosis characterized by decreased bacterial diversity, overgrowth of Bacteroides taxa, and lower SCFA, indole, and secondary bile acid production with biospecimen collections
研究概览
简要总结
The SARS-CoV-2 virus causes COVID-19, which ranges from mild initial symptoms to severe multi-organ dysfunction. While some patients recover to their baseline states, others develop a long COVID, or post-acute sequelae of SARS-CoV-2 (PASC) consisting of symptoms persisting >2-6 months post-infection. PASC symptoms include post-exertional malaise, fatigue, and heart palpitations as well as incident GI disorders, cognitive dysfunction, and arthritis. Based on prevalence/incidence studies, it is estimated that more than 30 million people in the US have ever developed PASC with 10-11% of patients or 11 million people continuing to feel symptoms to the present day10. SARS-CoV-2 vaccines are only ~32% effective against infection at 4 months post-vaccination11, only 15% effective against the development of PASC12, and only 20% of American adults have received an updated booster as of December 202313. It is therefore imperative that the scientific community make progress in identifying underlying causes of PASC to develop effective treatments.
This study will identify microbial metabolites associated with PASC-mediated gut dysbiosis and establish a tractable in vitro model to test T cell-gut epithelium dynamics to develop novel bio-therapeutics for multiple post-viral conditions. This case-control study will collect biospecimens (matched stool & blood) samples from 400 people with and without long COVID (200 participants/group) to understand how COVID-induced dysbiosis impacts symptom severity, immune suppression, and gut barrier dysfunction both ex vivo and in vitro.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-80
- •Race: Any
- •Last COVID infection: within past 3 years, PCR- or antigen-confirmed, symptomatic (mild/moderate/severe)
- •COVID vaccination status: Any
- •Presence of long COVID symptoms (GI, cardiac, pulmonary, neuro, musculoskeletal, and/or psych): 200 with symptoms, 200 w/o symptoms as defined by SBQ-LCTM.
- •May or may not be doing routine endoscopy at UCM
排除标准
- •Age <18 or >80
- •Last COVID infection >3 years ago (PCR/antigen-confirmed, symptomatic)
- •Currently or within the last 3 months COVID+ by nasopharyngeal PCR/antigen test
- •Currently diagnosed with cancer
- •Currently pregnant (cannot take colon biopsy sample; only eligible for survey/blood & stool collection)
- •Currently on biologic immunomodulatory medications
- •Official diagnosis of irritable bowel disease (IBD) or other chronic GI disorder
- •Vulnerable and/or Special Populations
- •Healthy adult volunteers
- •Pregnant people
- •UCMC and UChicago employees
- •Staff/faculty
研究组 & 干预措施
Subjects without Long COVID symptoms
We will enroll non-hospitalized patients recruited through the UCM long COVID clinic (headed by Dr. Rasika Karnik) and through the UCM Dept. of Gastroenterology endoscopy center under the umbrella Genesys protocol. We will also enroll convalescent subjects from the community without long COVID symptoms (only blood and stool samples collected from community participants, and they need not consent to the Genesys study to participate). All subjects will have had at least 1 PCR- or antigen-confirmed COVID-19 infection within the past 3 years and will be at least 60 days from their last SARS-CoV-2 infection.
干预措施: Subjects with and without Long COVID (Biological)
Subjects with Long COVID symptoms
We will enroll non-hospitalized patients recruited through the UCM long COVID clinic (headed by Dr. Rasika Karnik) and through the UCM Dept. of Gastroenterology endoscopy center under the umbrella Genesys protocol. We will also enroll convalescent subjects from the community with long COVID symptoms (only blood and stool samples collected from community participants, and they need not consent to the Genesys study to participate). All subjects will have had at least 1 PCR- or antigen-confirmed COVID-19 infection within the past 3 years and will be at least 60 days from their last SARS-CoV-2 infection.
干预措施: Subjects with and without Long COVID (Biological)
结局指标
主要结局
To determine whether people with long COVID exhibit microbial dysbiosis characterized by decreased bacterial diversity, overgrowth of Bacteroides taxa, and lower SCFA, indole, and secondary bile acid production with biospecimen collections
时间窗: At baseline until final values
次要结局
- To collect matched stool, blood, and intestinal biopsy samples from a cohort of 300 individuals with and without long COVID (150/group)(At baseline until final values)