NCT04552834

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Sep 2020Jun 2026

First Submitted

Initial submission to the registry

September 11, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

5.7 years

First QC Date

September 11, 2020

Last Update Submit

December 17, 2025

Conditions

Critical IllnessMicrobiome

Keywords

short term outcomeslong term outcomes

Outcome Measures

Primary Outcomes (1)

  • Long Term Mortality

    Death from any cause 90 day, 1 year

    up to 1 year

Secondary Outcomes (6)

  • hospital mortality

    28 day

  • ICU length of stay

    hospitalization up to 6 weeks

  • Hospital length of stay

    hospitalization up to 6 weeks

  • Functional Status Score

    up to 12 months after discharge

  • Cognitive Dysfunction

    Up to 12 months after discharge

  • +1 more secondary outcomes

Other Outcomes (3)

  • ICU re-admission

    up to 12 months

  • ICU related complications

    up to 6 weeks

  • Ventilator days

    up to 4 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult patients admitted to the intensive care unit

You may qualify if:

  • adult patients admitted to the intensive care unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

stool

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bhakti Patel

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 17, 2020

Study Start

September 15, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations

US(1)