Exploring the relationship between gut health and long COVID symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the connection between dysbiosis, or imbalances in gut microbiota, and the persistence of symptoms in individuals suffering from long COVID. It aims to enroll 400 participants, including 200 with long COVID symptoms and 200 without, all of whom must have had a confirmed COVID-19 infection within the last three years. The study will collect data through surveys, blood samples, and stool samples to analyze the gut microbiome's role in long COVID. The findings could provide insights into potential therapeutic targets for managing long COVID symptoms.

Why it matters

Who can join: the full rules

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

Where it's running

• The University of Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Lavanya Visvabharathy, Ph.D — University of Chicago
• Study coordinator: Lavanya Visvabharathy, Ph.D
• Email: lavanya.visvabharathy@bsd.uchicago.edu
• Phone: 773-834-5087

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.