NCT06825819Recruiting
Dysbiosis & Long COVID
DETERMINING THE IMPACT OF MICROBIAL DYSBIOSIS ON IMMUNE AND BARRIER DYSFUNCTION IN LONG COVID
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 11 Feb 2025
- Start date
- 21 Jan 2025
- Primary completion date
- Jan 2029
- Lead sponsor
- University of Chicago
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06825819
What you commit to
- Study type: Observational
- Planned participants: 400
- From 21 Jan 2025 to the primary completion date, Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently on biologic immunomodulatory medications
Other illness
- Currently or within the last 3 months COVID+ by nasopharyngeal PCR/antigen test
- Currently diagnosed with cancer
- Official diagnosis of irritable bowel disease (IBD) or other chronic GI disorder
- Vulnerable and/or Special Populations
Age
- Age \<18 or \>80
- Last COVID infection \>3 years ago (PCR/antigen-confirmed, symptomatic)
Other
- Currently pregnant (cannot take colon biopsy sample; only eligible for survey/blood \& stool collection)
- Healthy adult volunteers
- Pregnant people
- UCMC and UChicago employees
- Staff/faculty
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University Of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.