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

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03153397
• Collaborator: Abbott (Industry)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 43.2
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Enteral Nutrition; Brain Injuries, Traumatic; ICU Admission	Other: Nutraflora scFOS; Other: Osmolite	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 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: Oct 23, 2017
• Actual Primary Completion Date: Feb 20, 2021
• Actual Study Completion Date: May 31, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Changes in microbiome [Baseline (within 48 hours of ICU admission), up to 10 days]

   Stool samples

2. Overall microbiome composition sampling gut [Baseline (within 48 hours of ICU admission), up to 10 days]

   Stool samples

3. Change in microbiome longitudinally [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 [Baseline (within 48 hours of ICU admission), up to 10 days]

   Stool samples

Secondary Outcome Measures

1. Record length of mechanical ventilation [Up to 60 days]

2. Length of ICU [Up to 60 days]

3. Length of hospital stay [Up to 60 days]

4. Mortality [Up to 60 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University
• Abbott

Investigators

• Principal Investigator: Paul Wischmeyer, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03153397
• Other Study ID Numbers: Pro00081414
• First Posted: May 15, 2017
• Last Update Posted: Jun 4, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: trauma; brain; neurological; injury; enteral; tube; feeding; nutrition
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Trauma, Nervous System; Wounds and Injuries

Study Results

No Results Posted as of Jun 4, 2021