Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial)

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial)

Conditions
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ICU Admission, Enteral Nutrition, Brain Injuries, Traumatic

Intervention / Treatment
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* Other: Nutraflora scFOS
* Other: Osmolite


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult major neurological injury trauma patients between 18-70 years of age who have been admitted directly to trauma ICU following major trauma Expected length of mechanical ventilation > 48 hours (as judged by admitting clinician) Expected length of ICU stay > 3 days (as judged by admitting clinician) Expected to survive > 48 hours (as judged by admitting clinician) Requiring enteral nutrition at any time in Intensive Care Unit (ICU) stay Chronic illnesses must be under control (as determined by the Principal Investigator). Exclusion Criteria: Previous hospitalization within one month prior to ICU admission (no hospital floor transfers to eliminate confounding effect of previous hospital therapy) Use of prebiotic fiber containing enteral or oral formula or probiotic preparations within one week Received antibiotics within the previous month On steroids or immunosuppressants at time of admission All transplant patients Chronic inflammatory disease that requires steroids or other biologic therapy intervention (e.g.: RA, IBD that requires steroids or Humira) Undergoing active chemotherapy/radiation treatment Renal failure requiring dialysis Liver cirrhosis class C

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutraflora scFOS<br>prebiotic fiber-containing formula (Nutraflora scFOS) | Other: Nutraflora scFOS<br>* prebiotic fiber (Nutraflora scFOS via Vital AF)<br>|
| Active Comparator: Osmolite<br>non-prebiotic fiber containing formula (Osmolite) | Other: Osmolite<br>* non-prebiotic fiber containing formula (Osmolite)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in microbiome | Stool samples | Baseline (within 48 hours of ICU admission), up to 10 days | 
| Overall microbiome composition sampling gut | Stool samples | Baseline (within 48 hours of ICU admission), up to 10 days | 
| Change in microbiome longitudinally | Tongue swab microbiome longitudinally | Baseline at Day 2, 4, 6, 8 and 10 | 
| Changes in the microbiome on delivery of initial clinical outcomes in trauma patients | Stool samples | Baseline (within 48 hours of ICU admission), up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurological, trauma, brain, injury, enteral, tube, feeding, nutrition