Actively Recruiting

Age: 18Years - 85Years
All Genders
Healthy Volunteers
ID06822465

Pathobiomes in Gut of Critically Ill Patients

Led by University of Chicago · Updated on 2026-02-02

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Chicago

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research focuses on critically ill surgical patients who are at high risk of having their intestinal tracts colonized by Pseudomonas aeruginosa, a bacterium linked to a fourfold increase in mortality. Many patients who survive initial trauma may still face severe infections and organ failure due to gut-derived sepsis, caused by damage to the intestinal lining and changes in gut defense mechanisms. The study aims to understand how the intestinal environment influences the virulence of P. aeruginosa and its role in patient outcomes. The study involves collecting stool samples from critically ill patients admitted to intensive care units. These samples will be tested in laboratory experiments using in vitro and in vivo assays to evaluate their ability to activate virulence in laboratory strains of P. aeruginosa. Researchers will also isolate and study the strains of P. aeruginosa present in patients' intestines to determine how common this bacterium is in this population. Participants will provide stool samples during their stay in the burn, surgical, or medical intensive care units. The samples will undergo various laboratory tests, including pyocyanin screening assays and a C. elegans lethality model, to assess virulence-inducing properties. Additionally, PCR array analysis will be used to identify specific virulence genes activated by the stool filtrates. The study will continue for about three years, monitoring these outcomes to better understand the interaction between host factors and bacterial virulence.

CONDITIONS

Brief Title

Pathobiomes in Gut of Critically Ill Patients

Who Can Participate

Age: 18Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Any ethnicity
  • Age greater than 18 years and less than 85 years
Not Eligible

You will not qualify if you...

  • Known history of HIV/AIDS
  • Active pregnancy
  • Currently incarcerated

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Sample Collection

Duration - Up to 3 years

Participants provide stool samples for laboratory analysis of P. aeruginosa virulence and prevalence.

Periodic sample collections during ICU stay

Long-term Monitoring

Duration - Up to 3 years

Participants are monitored through laboratory assays to assess virulence induction and genetic analysis of P. aeruginosa from stool samples.

No direct visits required from participants during this phase

Trial Site Locations

Total: 1 location

1

The University of Chicago

Hyde Park, Illinois, United States, 60637

Actively Recruiting

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Research Team

J

John Alverdy, MD FACS FSIS

L

Leila Yazdanbakhsh, MSCI

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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