NCT03153397

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

October 23, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

June 4, 2021

Status Verified

May 1, 2021

Enrollment Period

3.3 years

First QC Date

May 11, 2017

Last Update Submit

June 2, 2021

Conditions

Enteral NutritionBrain Injuries, TraumaticICU Admission

Keywords

traumabrainneurologicalinjuryenteraltubefeedingnutrition

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

Nutraflora scFOS

EXPERIMENTAL

prebiotic fiber-containing formula (Nutraflora scFOS)

Other: Nutraflora scFOS

Osmolite

ACTIVE COMPARATOR

non-prebiotic fiber containing formula (Osmolite)

Other: Osmolite

Interventions

Nutraflora scFOSOTHER

prebiotic fiber (Nutraflora scFOS via Vital AF)

Nutraflora scFOS
OsmoliteOTHER

non-prebiotic fiber containing formula (Osmolite)

Osmolite

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • Serbanescu MA, Wright MC, Elebasy M, Shi P, Arnold JW, Haines KL, White JR, Surana NK, Wischmeyer PE. Impact of fiber-containing enteral nutrition on microbial community dynamics in critically ill trauma patients: a pilot-randomized trial. BMC Med. 2025 Dec 29;23(1):706. doi: 10.1186/s12916-025-04511-2.

    PMID: 41462238DERIVED

MeSH Terms

Conditions

Brain Injuries, TraumaticWounds and InjuriesNeurologic Manifestations

Interventions

Osmolite

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paul Wischmeyer, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 15, 2017

Study Start

October 23, 2017

Primary Completion

February 20, 2021

Study Completion

May 31, 2021

Last Updated

June 4, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)