Skip to main content
OpenTrials
Completed

NCT Number: NCT03153397

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Enteral Nutrition Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma ICU Admission Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutraflora scFOS

Other

prebiotic fiber (Nutraflora scFOS via Vital AF)

Osmolite

Other

non-prebiotic fiber containing formula (Osmolite)

Primary outcomes

  1. Changes in microbiome

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

    Stool samples

  2. Overall microbiome composition sampling gut

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

    Stool samples

  3. Change in microbiome longitudinally

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

    Tongue swab microbiome longitudinally

  4. 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

Secondary outcomes

  1. Record length of mechanical ventilation

    Time frame: Up to 60 days

  2. Length of ICU

    Time frame: Up to 60 days

  3. Length of hospital stay

    Time frame: Up to 60 days

  4. Mortality

    Time frame: Up to 60 days

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Abbott

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 15, 2017
Registry last updated
Jun 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.