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

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 Overview

• Status: Completed
• Conditions: Brain Injuries, Traumatic; Enteral Nutrition; ICU Admission
• Intervention / Treatment: Other: Nutraflora scFOS; Other: Osmolite

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Abbott
• Investigators: Principal Investigator: Paul Wischmeyer, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2017
• Primary Completion (Actual): February 20, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: trauma; nutrition; injury; brain; feeding; neurological; tube; enteral
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Trauma, Nervous System
• Other Study ID Numbers: Pro00081414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No