NCT04552834

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Illness
• Microbiome

Timeline

• Start date: 2020-09-15
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2020-09-17
• Last updated: 2025-12-19

Locations

1 site across 1 country: United States