Brain Injuries, Traumatic, Enteral Nutrition, ICU Admission
Conditions
Keywords
trauma, brain, neurological, injury, enteral, tube, feeding, nutrition
Brief summary
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.
Interventions
OTHERNutraflora scFOS
prebiotic fiber (Nutraflora scFOS via Vital AF)
OTHEROsmolite
non-prebiotic fiber containing formula (Osmolite)
Sponsors
Abbott
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Adult major neurological injury trauma patients between 18-70 years of age who have been admitted directly to trauma ICU following major trauma 2. Expected length of mechanical ventilation \> 48 hours (as judged by admitting clinician) 3. Expected length of ICU stay \> 3 days (as judged by admitting clinician) 4. Expected to survive \> 48 hours (as judged by admitting clinician) 5. Requiring enteral nutrition at any time in Intensive Care Unit (ICU) stay 6. Chronic illnesses must be under control (as determined by the Principal Investigator).
Exclusion criteria
1. Previous hospitalization within one month prior to ICU admission (no hospital floor transfers to eliminate confounding effect of previous hospital therapy) 2. Use of prebiotic fiber containing enteral or oral formula or probiotic preparations within one week 3. Received antibiotics within the previous month 4. On steroids or immunosuppressants at time of admission 5. All transplant patients 6. Chronic inflammatory disease that requires steroids or other biologic therapy intervention (e.g.: RA, IBD that requires steroids or Humira) 7. Undergoing active chemotherapy/radiation treatment 8. Renal failure requiring dialysis 9. Liver cirrhosis class C
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the microbiome on delivery of initial clinical outcomes in trauma patients | Baseline (within 48 hours of ICU admission), up to 10 days | Stool samples |
| Changes in microbiome | Baseline (within 48 hours of ICU admission), up to 10 days | Stool samples |
| Overall microbiome composition sampling gut | Baseline (within 48 hours of ICU admission), up to 10 days | Stool samples |
| Change in microbiome longitudinally | Baseline at Day 2, 4, 6, 8 and 10 | Tongue swab microbiome longitudinally |
Secondary
| Measure | Time frame |
|---|---|
| Record length of mechanical ventilation | Up to 60 days |
| Length of ICU | Up to 60 days |
| Length of hospital stay | Up to 60 days |
| Mortality | Up to 60 days |
Countries
United States
Outcome results
None listed