NCT03153397 is a NA clinical trial of Nutraflora scFOS in Enteral Nutrition, sponsored by Duke University.

Who is sponsoring NCT03153397?

NCT03153397 is sponsored by Duke University.

What drugs are being tested in NCT03153397?

Interventions in NCT03153397: Nutraflora scFOS, Osmolite.

What condition does NCT03153397 study?

NCT03153397 studies Enteral Nutrition, Brain Injuries, Traumatic, ICU Admission.

Is NCT03153397 still recruiting?

NCT03153397 is currently completed. Last updated 4 June 2021.

Last reviewed 2021-06-04 · How we verify

NCT03153397

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 4 June 2021

What this trial tests

NA trial testing Nutraflora scFOS in Enteral Nutrition in 20 participants. Completed in 31 May 2021.

Timeline

23 October 2017

Primary endpoint
20 February 2021

31 May 2021

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	23 October 2017
Primary completion	20 February 2021
Estimated completion	31 May 2021
Sites	1 location across United States

Drugs / interventions tested

Nutraflora scFOS
Osmolite

Conditions studied

Enteral Nutrition — all drugs for Enteral Nutrition →
Brain Injuries, Traumatic — all drugs for Brain Injuries, Traumatic →
ICU Admission — all drugs for ICU Admission →

Sponsor

Duke University

Who can join

Adults 18 to 70, any sex, with Enteral Nutrition or Brain Injuries, Traumatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Impact of fiber-containing enteral nutrition on microbial community dynamics in critically ill trauma patients: a pilot-randomized trial.
Serbanescu MA, Wright MC, Elebasy M, Shi P, et al · · 2025 · PMID 41462238 · DOI 10.1186/s12916-025-04511-2
Impact of Fiber-Containing Enteral Nutrition on Microbial Community Dynamics in Critically Ill Trauma Patients: A Pilot-Randomized Trial
Serbanescu MA, Wright MC, Arnold J, White JR, et al · · 2024 · DOI 10.21203/rs.3.rs-4583745/v1

Verify or expand the search:

Other recruiting trials for Enteral Nutrition

Currently open trials in the same condition.

NCT07307027 — Stepwise Enteral Nutritional Algorithm and Patient Outcomes in Pediatric Intensive Care Units · NA · recruiting

Other Duke University trials

Trials by the same sponsor.

NCT07216456 — Vaginal Dilator Therapy After Pelvic Radiation · NA · not yet recruiting
NCT07519317 — Dosing and Deployment Trial: A Home-based Optokinetic Treatment · NA · not yet recruiting
NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
NCT07216963 — The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services Study · NA · not yet recruiting
NCT07459218 — IDEAS for Hope to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03153397 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 4 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03153397.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing