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NCT05357170

Microbiome Dysfunction in Surgical Intensive Care Unit Survivors

Recruiting now Last updated 12 June 2025
What this trial tests

trial testing Human feces collection in Sepsis, Trauma Injury in 468 participants. Currently enrolling.

Timeline
21 June 2022
Primary endpoint
31 May 2027
31 May 2028

Quick facts

Lead sponsorUniversity of Florida
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment468
Start date21 June 2022
Primary completion31 May 2027
Estimated completion31 May 2028
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Florida

Who can join

Adults 18 to 110, any sex, with Sepsis, Trauma Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Oral and gastrointestinal microbiome dysfunction has been demonstrated to be a culprit of various systemic dysfunctions in peripheries such as cardiovascular, nervous, endocrine and musculoskeletal systems. The topic of microbiome dysfunction after surgical intensive care admission is understudied but may be responsible for persistent systemic inflammation clinically observed in surgical intensive care patients. Therefore, the objective of this project is to investigate the oral and gut microbiome after the acute phase of sepsis, severe trauma injury, cardiopulmonary bypass, and major vascular surgery to compare with 108 age-matched healthy population controls

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Gut mycobiome dysbiosis after sepsis and trauma.
    Park G, Munley JA, Kelly LS, Kannan KB, et al · · 2024 · cited 22× · PMID 38212826 · DOI 10.1186/s13054-023-04780-4
  2. Persistence and Sexual Dimorphism of Gut Dysbiosis and Pathobiome after Sepsis and Trauma.
    Munley JA, Park G, Kelly LS, Kannan KB, et al · · 2024 · cited 3× · PMID 38864230 · DOI 10.1097/sla.0000000000006385

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Data sources for this page

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