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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04552834

Enrollment

500

Registered

2020-09-17

Start date

2020-09-15

Completion date

2027-11-01

Last updated

2026-07-13

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

Conditions

Critical Illness, Microbiome

Keywords

short term outcomes, long term outcomes

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

adult patients admitted to the intensive care unit

Exclusion criteria

none

Design outcomes

Primary

Measure	Time frame	Description
Long Term Mortality	up to 1 year	Death from any cause 90 day, 1 year

Secondary

Measure	Time frame	Description
hospital mortality	28 day	death from any cause during hospitalization
ICU length of stay	hospitalization up to 6 weeks	number of days admitted to the ICU
Hospital length of stay	hospitalization up to 6 weeks	number of days admitted to the hospital
Functional Status Score	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
Cognitive Dysfunction	Up to 12 months after discharge	Montreal Cognitive Assessment (MoCA) score; minimal score = 0; maximum score = 30; higher score better outcome
Quality of Life score	up to 12 months after discharge	SF-36 score: including physical component summary (PCS) and mental component summary (MCS)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBhakti Patel

University of Chicago

Outcome results