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NCT03153397 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
20
Enrollment target

NCT03153397: Completed NA study, sponsored by Duke University.

NCT03153397 is a NA study that has completed, run by Duke University. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03153397, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target

Study 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.

Primary Outcome

Stool samples

Interventions

  • OTHER Nutraflora scFOS
  • OTHER Osmolite

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2017-10-23
Est. Completion 2021-05-31
Phase NA
Duke University

1,725 total trials

What the finished NCT03153397 record still lists

NCT03153397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Nutraflora scFOS is the first listed.

NCT03153397 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03153397 about?

NCT03153397 is a clinical study titled "Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial)". 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 bact...

What is the current status of trial NCT03153397?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2017-10-23. Estimated completion is 2021-05-31.

What interventions are being tested in trial NCT03153397?

The interventions under investigation include: Nutraflora scFOS (OTHER), Osmolite (OTHER).

Who is sponsoring clinical trial NCT03153397?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03153397's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03153397, the US trial registry maintained by the National Library of Medicine. NCT03153397 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.