Gut Microbiome Dysfunction in Sepsis and Trauma Survivors

Recruiting

• Conditions: Sepsis, Trauma Injury
• Interventions: Other: Human feces collection

• Registration Number: NCT05357170
• Lead Sponsor: University of Florida

Brief Summary

Gastrointestinal microbiome dysfunction has been demonstrated to be a culprit of various systemic dysfunctions in peripheries such as cardiovascular, nervous, endocrine and musculoskeletal systems. The topic of microbiome dysfunction after sepsis and trauma injury is understudied but may be responsible for persistent systemic inflammation clinically observed in sepsis and trauma survivors. Therefore, the objective of this project is to investigate the gut microbiome after acute phase of sepsis or severe trauma injury and compare it with 108 age-matched healthy population controls

Detailed Description

The investigators hypothesize that alterations of the gut microbiota will correlate with persistent systemic inflammation in sepsis and trauma survivors compared to existing healthy population controls. This research group will collect stool samples from 108 sepsis survivors and 108 trauma survivors (groups of ages 18-45, 46-64, and \>65; male and female; n=18 per age + sex cohort) admitted to the surgical intensive care unit between day 7 and 28 of hospital admission, as well as 3 and 6 months after their sepsis or trauma event. The investigators will perform 16S rRNA DNA sequencing on the isolated bacterial DNA from these samples and bioinformatic analysis to determine microbiota alterations between time points and between sepsis and control cohorts. In addition, the investigators will draw 20ml of blood to isolate plasma.

Trauma Subgroup for traumatic brain injury (TBI) pilot study: Our team will enroll 15 additional trauma injury patients with traumatic brain injury. This subgroup will have an added stool (if available) and blood sample collection after initial injury (+ 5 days). The additional sample will be compared to the sample collected at 14-21 days and follow up samples at 3 and 6 months. The results will be associated with Glasgow Outcome Scale Extended at 3 and 12 month time points and the recorded discharge Rancho Los Amigos scale score from the medical record. The specific aims will be: Aim 1 - define the impact of persistent systemic inflammation on the gastrointestinal microbiota in sepsis and trauma survivors and Aim 2 - identify microbial genes associated with persistent systemic inflammation in sepsis and trauma survivors compared to normal controls. Trauma Subgroup Aim: Pilot study to test the hypothesis that changes in the microbiome towards pathogenic microbe is associated with worsened outcomes in trauma injury patients with TBI (traumatic brain injury).

Study Timeline

• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-05-02
• Study Start: 2022-06-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2025-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 468

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Control Population	Human feces collection	One time collection of feces and blood upon enrollment used for comparison to identify microbial genes associated with persistent systemic inflammation in sepsis survivors.
Trauma Survivor	Human feces collection	Feces collected between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months. Blood will be collected at time of first feces collection
Traumatic Brain Injury (TBI)	Human feces collection	Feces collected at admission (day 1(+5)) and between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months. Blood will be collected at time of first and second feces collection.
Sepsis Survivors	Human feces collection	Feces collected between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months. Blood will be collected at time of first feces collection

Primary Outcome Measures

Name	Time	Method
Determine the impact of persistent systemic inflammation on gastrointestinal microbiota in sepsis and trauma survivors & identify microbial genes associated with persistent systemic inflammation of sepsis & trauma survivors compared to normal controls.	through study completion, an average of 6 months	Identify gut microbiome dysfunction through Microbial Taxonomic Analysis and Meta-transcriptomic Analysis

Trial Locations

Locations (1)

UF Health at Shands Hospital; 🇺🇸 Gainesville, Florida, United States