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

NCT ID: NCT04552834

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-15

Study Completion Date

2026-06-01

Brief Summary

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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

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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.

Conditions

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Critical Illness Microbiome

Keywords

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short term outcomes long term outcomes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

adult patients admitted to the intensive care unit
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bhakti Patel

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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20-1102

Identifier Type: -

Identifier Source: org_study_id