Alterations of the Microbiome During Critical Illness Wit... | NCT04552834

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

NCT04552834

Sponsor

University of Chicago

Status

Active, not recruiting

Last Update Posted

Dec 19, 2025Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Critical Illness
Microbiome

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2020Actual

Primary Completion Date

Jun 1, 2026Estimated

Completion Date

Jun 1, 2026Estimated

First Submitted Date

Sep 11, 2020

First Submission Date that Met QC Criteria

Sep 11, 2020

First Posted Date

Sep 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2025

Last Update Posted Date

Dec 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
hospital mortality	death from any cause during hospitalization	28 day
ICU length of stay	number of days admitted to the ICU	hospitalization up to 6 weeks

Other Outcomes

Measure	Description	Time Frame
ICU re-admission	number of admissions to ICU	up to 12 months
ICU related complications	presence of ICU complications: including ventilator associated pneumonia, GI hemorrhage, DVT/PE, sacral decubitus ulcer, delirium, ICU acquired weakness

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients admitted to the intensive care unit

Exclusion Criteria: none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

adult patients admitted to the intensive care unit

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bhakti Patel	University of Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Chicago Medical Center		Chicago	Illinois	60637	United States

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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