CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Nutraflora scFOS +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03153397
NCT03153397N/ACompleted

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

Duke University·interventional·Posted May 15, 2017·Updated Jun 4, 2021

In Brief

A clinical study evaluating Nutraflora scFOS and Osmolite for Enteral Nutrition and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAbbott

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 15, 2017
Enrollment StartOct 23, 2017
Primary CompletionFeb 20, 2021
Study CompletionMay 31, 2021
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 9.1 years ago

Interventions

Nutraflora scFOSother

prebiotic fiber (Nutraflora scFOS via Vital AF)

Osmoliteother

non-prebiotic fiber containing formula (Osmolite)