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Clinical Trials/NCT03153397
NCT03153397CompletedNot Applicable

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

Duke University2 sites in 1 country20 target enrollmentStarted: October 23, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
2
Primary Endpoint
Change in microbiome longitudinally

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change in microbiome longitudinally

Time Frame: Baseline at Day 2, 4, 6, 8 and 10

Tongue swab microbiome longitudinally

Changes in the microbiome on delivery of initial clinical outcomes in trauma patients

Time Frame: Baseline (within 48 hours of ICU admission), up to 10 days

Stool samples

Changes in microbiome

Time Frame: Baseline (within 48 hours of ICU admission), up to 10 days

Stool samples

Overall microbiome composition sampling gut

Time Frame: Baseline (within 48 hours of ICU admission), up to 10 days

Stool samples

Secondary Outcomes

  • Record length of mechanical ventilation(Up to 60 days)
  • Length of hospital stay(Up to 60 days)
  • Mortality(Up to 60 days)
  • Length of ICU(Up to 60 days)

Investigators

Sponsor
Duke University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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