RECRUITING

Dysbiosis & Long COVID

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

DETERMINING THE IMPACT OF MICROBIAL DYSBIOSIS ON IMMUNE AND BARRIER DYSFUNCTION IN LONG COVID

Quick Facts

Study Start:2025-01-21
Study Completion:2029-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06825819

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: 18-80
  2. * Sex: Any
  3. * Race: Any
  4. * Last COVID infection: within past 3 years, PCR- or antigen-confirmed, symptomatic (mild/moderate/severe)
  5. * COVID vaccination status: Any
  6. * 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.
  7. * May or may not be doing routine endoscopy at UCM
  1. * Age \<18 or \>80
  2. * Last COVID infection \>3 years ago (PCR/antigen-confirmed, symptomatic)
  3. * Currently or within the last 3 months COVID+ by nasopharyngeal PCR/antigen test
  4. * Currently diagnosed with cancer
  5. * Currently pregnant (cannot take colon biopsy sample; only eligible for survey/blood \& stool collection)
  6. * Currently on biologic immunomodulatory medications
  7. * Official diagnosis of irritable bowel disease (IBD) or other chronic GI disorder
  8. * Healthy adult volunteers
  9. * Pregnant people
  10. * UCMC and UChicago employees
  11. * Staff/faculty

Contacts and Locations

Study Contact

Lavanya Visvabharathy, Ph.D
CONTACT
773-834-5087
lavanya.visvabharathy@bsd.uchicago.edu
Leila Yazdanbakhsh, MSCI
CONTACT
7738345087
leila.yazdanbakhsh@bsd.uchicago.edu

Principal Investigator

Lavanya Visvabharathy, Ph.D
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

The University of Chicago
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Lavanya Visvabharathy, Ph.D, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-21
Study Completion Date2029-01

Study Record Updates

Study Start Date2025-01-21
Study Completion Date2029-01

Terms related to this study

Additional Relevant MeSH Terms

  • COVID-19