Clinical trial NCT03153397: Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial)
Official title: Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Nutrition
Brain Injuries, Traumatic
ICU Admission
Keywords: trauma
brain
neurological
injury
enteral
tube
feeding
nutrition
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2017-05-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in microbiome
timeFrame: Baseline (within 48 hours of ICU admission), up to 10 days
measure: Overall microbiome composition sampling gut
timeFrame: Baseline (within 48 hours of ICU admission), up to 10 days
measure: Change in microbiome longitudinally
timeFrame: Baseline at Day 2, 4, 6, 8 and 10
measure: Changes in the microbiome on delivery of initial clinical outcomes in trauma patients
timeFrame: Baseline (within 48 hours of ICU admission), up to 10 days
Secondary outcomes:
measure: Record length of mechanical ventilation
timeFrame: Up to 60 days
measure: Length of ICU
timeFrame: Up to 60 days
measure: Length of hospital stay
timeFrame: Up to 60 days
measure: Mortality
timeFrame: Up to 60 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Paul Wischmeyer, MD
role: PRINCIPAL_INVESTIGATOR
References: