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

Brain Injuries, Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03153397
• Other study ID #: Pro00081414
• Status: Completed
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: May 31, 2021

Study information

• Verified date: May 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 31, 2021
• Est. primary completion date: February 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Enteral Nutrition
• ICU Admission
• Trauma, Nervous System
• Wounds and Injuries

Intervention

Other:
• Nutraflora scFOS
prebiotic fiber (Nutraflora scFOS via Vital AF)
• Osmolite
non-prebiotic fiber containing formula (Osmolite)

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in microbiome	Stool samples	Baseline (within 48 hours of ICU admission), up to 10 days
Primary	Overall microbiome composition sampling gut	Stool samples	Baseline (within 48 hours of ICU admission), up to 10 days
Primary	Change in microbiome longitudinally	Tongue swab microbiome longitudinally	Baseline at Day 2, 4, 6, 8 and 10
Primary	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	Record length of mechanical ventilation		Up to 60 days
Secondary	Length of ICU		Up to 60 days
Secondary	Length of hospital stay		Up to 60 days
Secondary	Mortality		Up to 60 days