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Pathobiomes in Gut of Critically Ill Patients

Pathobiomes in Gut of Critically Ill Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06822465
Enrollment
100
Registered
2025-02-12
Start date
2024-12-19
Completion date
2029-12-01
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudomonas Aeruginosa

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.

Interventions

OTHERP. aeruginosa using in vitro and in vivo assays

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 investigators also plan 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.

Sponsors

University of Chicago
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
PCR array analysis of known P. aeruginosa virulence genes following exposure to stool sample filtrate deemed to be highly activating by the in vitro pyocyanin assay and in vivo C. elegans lethality model.Through study completion, an average of 3 years
In vitro pyocyanin screening assay to determine if a stool sample has any virulence inducing ability on laboratory strains of P. aeruginosaThrough study completion, an average of 3 years
In vivo C. elegans lethality model to determine if liquid media culture "spiked" with stool sample filtrate will induce a lethal phenotype in laboratory strains of P. aeruginosaThrough study completion, an average of 3 years

Countries

United States

Contacts

CONTACTJohn Alverdy, MD FACS FSIS
jalverdy@bsd.uchicago.edu773-702-4876
CONTACTLeila Yazdanbakhsh, MSCI
leila.yazdanbakhsh@bsd.uchicago.edu773-834-5087
PRINCIPAL_INVESTIGATORJohn Alverdy, MD FACS FSIS

University of Chicago

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026