Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04552834

Alterations of the Microbiome During Critical Illness With Short and Long Term Clinical Outcomes

This study is designed to study the variations in the microbiome among critically ill patients and the effect of admission to the medical intensive care unit (MICU) at the University of Chicago. Additionally, investigators will examine the downstream clinical effects of dysbiosis in ICU patients and how patients maybe effected long term.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Critical Illness Disease Attributes Microbiome Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

About this study

During this study investigators will longitudinally collect discarded stool biosamples throughout the MICU admission when available. Stool Bio specimens will be recorded/coded and processed by the investigators. Stool Bio specimens will be analyzed for 16sRNA and metabolomics. Surveys will be conducted at study entry, in addition to 6 months and 12 months following discharge.

By longitudinally sampling discarded biospecimens from subjects throughout their MICU admission in additionally to describing long term following up. We will be able to correlate changes in the microbiome with clinical data, and follow up surveys to identify factors that may impact the composition of the microbiome and their impact on clinical outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

adult patients admitted to the intensive care unit

Exclusion criteria

none

Treatment and study plan

Primary outcomes

  1. Long Term Mortality

    Time frame: up to 1 year

    Death from any cause 90 day, 1 year

Secondary outcomes

  1. hospital mortality

    Time frame: 28 day

    death from any cause during hospitalization

  2. ICU length of stay

    Time frame: hospitalization up to 6 weeks

    number of days admitted to the ICU

  3. Hospital length of stay

    Time frame: hospitalization up to 6 weeks

    number of days admitted to the hospital

  4. Functional Status Score

    Time frame: up to 12 months after discharge

    Katz Index of Independence in activities of daily living; minimal score = 0; maximum score = 6; higher score better outcome

  5. Cognitive Dysfunction

    Time frame: Up to 12 months after discharge

    Montreal Cognitive Assessment (MoCA) score; minimal score = 0; maximum score = 30; higher score better outcome

  6. Quality of Life score

    Time frame: up to 12 months after discharge

    SF-36 score: including physical component summary (PCS) and mental component summary (MCS)

Other outcomes

  1. ICU re-admission

    Time frame: up to 12 months

    number of admissions to ICU

  2. ICU related complications

    Time frame: up to 6 weeks

    presence of ICU complications: including ventilator associated pneumonia, GI hemorrhage, DVT/PE, sacral decubitus ulcer, delirium, ICU acquired weakness

  3. Ventilator days

    Time frame: up to 4 weeks

    duration of mechanical ventilation via endotracheal tube

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Sep 17, 2020
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.