RECRUITING

Pathobiomes in Gut of Critically Ill Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pathobiomes in Gut of Critically Ill Patients

Quick Facts

Study Start:2024-12-19
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06822465

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Any ethnicity
  2. * Age \> 18 years and \< 85 years
  1. * A known history of HIV/AIDS
  2. * Active pregnancy
  3. * Are incarcerated will be excluded from the study.

Contacts and Locations

Study Contact

John Alverdy, MD FACS FSIS
CONTACT
773-702-4876
jalverdy@bsd.uchicago.edu
Leila Yazdanbakhsh, MSCI
CONTACT
773-834-5087
leila.yazdanbakhsh@bsd.uchicago.edu

Principal Investigator

John Alverdy, MD FACS FSIS
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

The University of Chicago
Hyde Park, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • John Alverdy, MD FACS FSIS, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-19
Study Completion Date2029-12

Study Record Updates

Study Start Date2024-12-19
Study Completion Date2029-12

Terms related to this study

Additional Relevant MeSH Terms

  • Pseudomonas Aeruginosa