NCT Number: NCT06825819
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Chicago, Illinois, 60637, United States
Location status: Recruiting
Lavanya Visvabharathy, Ph.D
CONTACT
Lavanya Visvabharathy, Ph.D
PRINCIPAL_INVESTIGATOR
Leila Yazdanbakhsh, MSCI
CONTACT
Rasika Karnik, MD
SUB_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Vulnerable and/or Special Populations
To 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.
Time frame: At baseline until final values
Time frame: At baseline until final values
Time frame: At baseline until final values
This will only be done if participants consent to both this study and the Genesys study.
Time frame: At baseline until final values
Time frame: At baseline until final values
This will only be done if participants consent to both this study and the Genesys study.
Time frame: At baseline until final values
Contact information is provided by the study sponsor or research team.
Lavanya Visvabharathy, Ph.D
CONTACT
Leila Yazdanbakhsh, MSCI
CONTACT
University of Chicago
Other
DETERMINING THE IMPACT OF MICROBIAL DYSBIOSIS ON IMMUNE AND BARRIER DYSFUNCTION IN LONG COVID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05787327
COVID-19, Coronaviridae Infections
Hong Kong
View Trial DetailsNCT07536308
COVID-19, Coronaviridae Infections
Decatur, Georgia, United States
View Trial DetailsNCT01306084
Adenoviridae Infections, Anogenital Herpes
Bethesda, Maryland, United States
View Trial DetailsNCT04330599
COVID-19, Coronaviridae Infections
London, County (optional), United Kingdom
View Trial Details