No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Observational
Participants needed
400 (estimated)
Sponsor
University of Chicago · Other
Who this trial is looking for
This trial is looking for people aged 18-80 who have had COVID-19 in the last 3 years. Participants will provide blood and stool samples to help researchers study long COVID and its effects on gut health.
Are You a Good Fit for This Trial?
Rules you outCancerPregnancyIrritable bowel diseaseChronic GI disorder
You may be able to join if
I am between 18 and 80 years old.
I have had a COVID-19 infection confirmed by a test within the last 3 years.
I have symptoms of long COVID or I do not have long COVID symptoms.
I can participate in the study whether or not I am having routine endoscopy.
You may not be able to join if
I am under 18 or over 80 years old.
My last COVID-19 infection was more than 3 years ago.
I am currently COVID-positive.
I have a cancer diagnosis.
I am currently pregnant.
I am on certain immunomodulatory medications.
I have been officially diagnosed with irritable bowel disease or chronic GI disorder.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 inciden…
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Age: 18-80
* Sex: Any
* 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 wi…
Inclusion Criteria:
* Age: 18-80
* Sex: Any
* 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
Exclusion Criteria:
* 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
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