NCT03153397

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Enteral Nutrition
• Brain Injuries, Traumatic
• ICU Admission

Interventions

Type	Name	Description
OTHER	Nutraflora scFOS	prebiotic fiber (Nutraflora scFOS via Vital AF)
OTHER	Osmolite	non-prebiotic fiber containing formula (Osmolite)

Timeline

• Start date: 2017-10-23
• Primary completion: 2021-02-20
• Completion: 2021-05-31
• First posted: 2017-05-15
• Last updated: 2021-06-04

Locations

1 site across 1 country: United States