Exploring the relationship between gut health and long COVID symptoms
DETERMINING THE IMPACT OF MICROBIAL DYSBIOSIS ON IMMUNE AND BARRIER DYSFUNCTION IN LONG COVID
This study is trying to see if problems with gut health are linked to ongoing symptoms in people who have long COVID.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06825819 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 who have had a confirmed COVID-19 infection within the last three years and either experience long COVID symptoms or do not.
Not a fit: Patients who are under 18 or over 80, have not had a COVID-19 infection in the last three years, or have certain chronic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new strategies for treating long COVID by targeting gut health.
How similar studies have performed: While the specific relationship between dysbiosis and long COVID is still being explored, similar studies on gut health and other post-viral syndromes have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Chicago, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.