Pathobiomes in Gut of Critically Ill Patients

Recruiting

• Conditions: Pseudomonas Aeruginosa

• Registration Number: NCT06822465
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-19
• Study First Submitted: 2025-01-28
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In vitro pyocyanin screening assay to determine if a stool sample has any virulence inducing ability on laboratory strains of P. aeruginosa	Through 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. aeruginosa	Through study completion, an average of 3 years
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

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Hyde Park, Illinois, United States