NCT03153397|Completed
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Sponsor study identifier
interventional
20
1 country
1
Study Start
October 23, 2017
Actual (reported)Primary Completion
February 20, 2021
Actual (reported)Study Completion
May 31, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 11, 2017
Actual (reported)May 15, 2017
Actual (reported)October 23, 2017
Actual (reported)February 20, 2021
Actual (reported)May 31, 2021
Actual (reported)Changes in microbiome
Stool samples
Baseline (within 48 hours of ICU admission), up to 10 days
Overall microbiome composition sampling gut
Stool samples
Baseline (within 48 hours of ICU admission), up to 10 days
Change in microbiome longitudinally
Tongue swab microbiome longitudinally
Baseline at Day 2, 4, 6, 8 and 10
prebiotic fiber-containing formula (Nutraflora scFOS)
non-prebiotic fiber containing formula (Osmolite)
prebiotic fiber (Nutraflora scFOS via Vital AF)
non-prebiotic fiber containing formula (Osmolite)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Duke University Medical Center
Durham, North Carolina, 27710, United States
Serbanescu MA, Wright MC, Elebasy M, Shi P, Arnold JW, Haines KL, White JR, Surana NK, Wischmeyer PE. Impact of fiber-containing enteral nutrition on microbial community dynamics in critically ill trauma patients: a pilot-randomized trial. BMC Med. 2025 Dec 29;23(1):706. doi: 10.1186/s12916-025-04511-2.
Paul Wischmeyer, MD
Duke University
20 participants (actual enrollment reported by the registry).
First Submitted
May 11, 2017
First Posted
May 15, 2017
Study Start
October 23, 2017
Actual (reported)TubeClear® Evaluation in Pediatric Patients (Phase I)
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
Record length of mechanical ventilation
Up to 60 days
Length of ICU
Up to 60 days
Length of hospital stay
Up to 60 days
Mortality
Up to 60 days
Contact the study team to confirm eligibility.
Primary Completion
February 20, 2021
Actual (reported)Study Completion
May 31, 2021
Actual (reported)Last Updated
June 4, 2021
Record last verified: 2021-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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