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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03153397
Recruitment Status : Suspended (COVID-19)
First Posted : May 15, 2017
Last Update Posted : April 30, 2020
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Enteral Nutrition Brain Injuries, Traumatic ICU Admission Other: Nutraflora scFOS Other: Osmolite Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial)
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

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)

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03153397

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
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Principal Investigator: Paul Wischmeyer, MD Duke University
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Responsible Party: Duke University Identifier: NCT03153397    
Other Study ID Numbers: Pro00081414
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Duke University:
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Trauma, Nervous System
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma