This study plans to learn more about the impact of enteral nutrition on bacteria in critically ill trauma patients with brain injury. Specifically, it seeks to understand the effect that a prebiotic containing enteral feeding formula (Nutraflora scFOS in Vital AF) has on the gut, oral, and skin bacteria. A prebiotic is a special form of dietary fiber that acts as a fertilizer for good bacteria. The prebiotic Nutraflora scFOS has been cleared by the U.S. Food and Drug Administration and is not considered investigational as used in this study. Enteral feeding is a way to give nutrition to critically ill people who are unable to eat.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
prebiotic fiber (Nutraflora scFOS via Vital AF)
non-prebiotic fiber containing formula (Osmolite)
Duke University Medical Center
Durham, North Carolina, United States
Changes in microbiome
Stool samples
Time frame: Baseline (within 48 hours of ICU admission), up to 10 days
Overall microbiome composition sampling gut
Stool samples
Time frame: Baseline (within 48 hours of ICU admission), up to 10 days
Change in microbiome longitudinally
Tongue swab microbiome longitudinally
Time frame: Baseline at Day 2, 4, 6, 8 and 10
Changes in the microbiome on delivery of initial clinical outcomes in trauma patients
Stool samples
Time frame: Baseline (within 48 hours of ICU admission), up to 10 days
Record length of mechanical ventilation
Time frame: Up to 60 days
Length of ICU
Time frame: Up to 60 days
Length of hospital stay
Time frame: Up to 60 days
Mortality
Time frame: Up to 60 days
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