Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial)
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 12/22/2018 |
| Start Date: | October 23, 2017 |
| End Date: | December 31, 2019 |
| Contact: | Paul Wischmeyer, MD |
| Email: | paul.wischmeyer@duke.edu |
| Phone: | (919)-681-9660 |
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.
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.
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 initiated within 72 hours of ICU admission
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
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