Back to resultsEffect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial)
Primary Purpose
Enteral Nutrition, Brain Injuries, Traumatic, ICU Admission
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutraflora scFOS
Osmolite
Sponsored by
About this trial
This is an interventional treatment trial for Enteral Nutrition focused on measuring trauma, brain, neurological, injury, enteral, tube, feeding, nutrition
Eligibility Criteria
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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nutraflora scFOS
Osmolite
Arm Description
prebiotic fiber-containing formula (Nutraflora scFOS)
non-prebiotic fiber containing formula (Osmolite)
Outcomes
Primary Outcome Measures
Changes in microbiome
Stool samples
Overall microbiome composition sampling gut
Stool samples
Change in microbiome longitudinally
Tongue swab microbiome longitudinally
Changes in the microbiome on delivery of initial clinical outcomes in trauma patients
Stool samples
Secondary Outcome Measures
Record length of mechanical ventilation
Length of ICU
Length of hospital stay
Mortality
Full Information
NCT ID
NCT03153397
First Posted
May 11, 2017
Last Updated
June 2, 2021
Sponsor
Duke University
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT03153397
Brief Title
Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial)
Official Title
Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
February 20, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Abbott
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enteral Nutrition, Brain Injuries, Traumatic, ICU Admission
Keywords
trauma, brain, neurological, injury, enteral, tube, feeding, nutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutraflora scFOS
Arm Type
Experimental
Arm Description
prebiotic fiber-containing formula (Nutraflora scFOS)
Arm Title
Osmolite
Arm Type
Active Comparator
Arm Description
non-prebiotic fiber containing formula (Osmolite)
Intervention Type
Other
Intervention Name(s)
Nutraflora scFOS
Intervention Description
prebiotic fiber (Nutraflora scFOS via Vital AF)
Intervention Type
Other
Intervention Name(s)
Osmolite
Intervention Description
non-prebiotic fiber containing formula (Osmolite)
Primary Outcome Measure Information:
Title
Changes in microbiome
Description
Stool samples
Time Frame
Baseline (within 48 hours of ICU admission), up to 10 days
Title
Overall microbiome composition sampling gut
Description
Stool samples
Time Frame
Baseline (within 48 hours of ICU admission), up to 10 days
Title
Change in microbiome longitudinally
Description
Tongue swab microbiome longitudinally
Time Frame
Baseline at Day 2, 4, 6, 8 and 10
Title
Changes in the microbiome on delivery of initial clinical outcomes in trauma patients
Description
Stool samples
Time Frame
Baseline (within 48 hours of ICU admission), up to 10 days
Secondary Outcome Measure Information:
Title
Record length of mechanical ventilation
Time Frame
Up to 60 days
Title
Length of ICU
Time Frame
Up to 60 days
Title
Length of hospital stay
Time Frame
Up to 60 days
Title
Mortality
Time Frame
Up to 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Wischmeyer, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial)
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