NCT06822465 Pathobiomes in Gut of Critically Ill Patients
| NCT ID | NCT06822465 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Chicago |
| Condition | Pseudomonas Aeruginosa |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-12-19 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-12-19 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Despite powerful antibiotics, 50% of the intestinal tracts of critically ill surgical patients are colonized by Pseudomonas aeruginosa, whose mere presence in this site increases mortality fourfold by mechanisms that remain unknown. Many patients who survive the initial surgical trauma still succumb to multi-organ failure and septicemia secondary to an invasive nosocomial infection. The sequelae of shock, hypoxia, and parental nutrition result in injury to the intestinal mucosa, changes in gut permeability, and failure of intestinal defense mechanisms. These conditions put patients at risk for infection and multiple organ failure secondary to the translocation of enteric bacteria, initiating a systemic release of inflammatory mediators-a process that has been termed gut-derived sepsis. Intestinal P. aeruginosa senses host factors released during stress and responds by activating its virulence gene machinery. As such, the presence of a highly activating intestinal milieu serves to induce virulence in strains of P. aeruginosa and this correlates to the severity of a patient's illness. While the host-pathogen interaction is a dynamic process, the study expects that as a patient's illness worsens or resolves over time, the "virulence-activating" properties of their intestinal milieu will change accordingly. This study will conduct a prospective observational trial in a population of critically ill patients at the Universtiy of Chicago Medical Center. This trial will entail collecting and screening stool samples obtained from critically ill patients for their virulence inducing capabilities on laboratory strains of P. aeruginosa using in vitro and in vivo assays. The study also plans to isolate strains of intestinal P. aeruginosa from stool samples to determine the prevalence of intestinal P. aeruginosa in a population of critically ill patients.
Eligibility Criteria
Inclusion Criteria: * Any ethnicity * Age \> 18 years and \< 85 years Exclusion Criteria: * A known history of HIV/AIDS * Active pregnancy * Are incarcerated will be excluded from the study.
Contact & Investigator
John Alverdy, MD FACS FSIS
PRINCIPAL INVESTIGATOR
University of Chicago
Frequently Asked Questions
Who can join the NCT06822465 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Pseudomonas Aeruginosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06822465 currently recruiting?
Yes, NCT06822465 is actively recruiting participants. Contact the research team at jalverdy@bsd.uchicago.edu for enrollment information.
Where is the NCT06822465 trial being conducted?
This trial is being conducted at Hyde Park, United States.
Who is sponsoring the NCT06822465 clinical trial?
NCT06822465 is sponsored by University of Chicago. The principal investigator is John Alverdy, MD FACS FSIS at University of Chicago. The trial plans to enroll 100 participants.