Enteral NutritionNCT03153397
Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial)
A study testing Nutraflora scFOS and Osmolite in people with Enteral Nutrition and Brain Injuries, Traumatic, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Enteral Nutrition, Brain Injuries, Traumatic, ICU Admission
- What is being tested?
- Nutraflora scFOS and Osmolite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2017to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult major neurological injury trauma patients between 18-70 years of age who have been admitted directly to trauma ICU following major trauma
- Expected length of mechanical ventilation > 48 hours (as judged by admitting clinician)
- Expected length of ICU stay > 3 days (as judged by admitting clinician)
- Expected to survive > 48 hours (as judged by admitting clinician)
- Requiring enteral nutrition at any time in Intensive Care Unit (ICU) stay
- Chronic illnesses must be under control (as determined by the Principal Investigator).
Who cannot join
- Previous hospitalization within one month prior to ICU admission (no hospital floor transfers to eliminate confounding effect of previous hospital therapy)
- Use of prebiotic fiber containing enteral or oral formula or probiotic preparations within one week
- Received antibiotics within the previous month
- On steroids or immunosuppressants at time of admission
- All transplant patients
- Chronic inflammatory disease that requires steroids or other biologic therapy intervention (e.g.: RA, IBD that requires steroids or Humira)
Show all 9Show fewer
- Undergoing active chemotherapy/radiation treatment
- Renal failure requiring dialysis
- Liver cirrhosis class C
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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
- Being tested
- Nutraflora scFOS, Osmolite
- Keywords
- trauma, brain, neurological, injury, enteral, tube, feeding, nutrition
- Medical subject headings
- Brain Injuries, Traumatic, Wounds and Injuries, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutraflora scFOSOther
prebiotic fiber (Nutraflora scFOS via Vital AF)
OsmoliteOther
non-prebiotic fiber containing formula (Osmolite)
| Study group | Role | What they receive |
|---|---|---|
| Nutraflora scFOS | Experimental | prebiotic fiber-containing formula (Nutraflora scFOS) Receives: Other: Nutraflora scFOS |
| Osmolite | Active comparator | non-prebiotic fiber containing formula (Osmolite) Receives: Other: Osmolite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in microbiome
Stool samples
Measured: Baseline (within 48 hours of ICU admission), up to 10 days
Overall microbiome composition sampling gut
Stool samples
Measured: Baseline (within 48 hours of ICU admission), up to 10 days
Change in microbiome longitudinally
Tongue swab microbiome longitudinally
Measured: Baseline at Day 2, 4, 6, 8 and 10
Changes in the microbiome on delivery of initial clinical outcomes in trauma patients
Stool samples
Measured: Baseline (within 48 hours of ICU admission), up to 10 days
Secondary outcomes (4)
Record length of mechanical ventilation
Measured: Up to 60 days
Length of ICU
Measured: Up to 60 days
Length of hospital stay
Measured: Up to 60 days
Mortality
Measured: Up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start23 Oct 2017
- Primary completion20 Feb 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Paul Wischmeyer, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153397
- Sponsor's protocol ID
- Pro00081414
- Status last verified
- May 2021
- First submitted
- 11 May 2017
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41462238
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial)
- ClinicalTrials.gov ID
- NCT03153397
- Acronym / sponsor ID
- Pro00081414
- Conditions
- Enteral Nutrition, Brain Injuries, Traumatic, ICU Admission
- Keywords
- trauma, brain, neurological, injury, enteral, tube, feeding, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutraflora scFOS | Experimental | Other: Nutraflora scFOSprebiotic fiber-containing formula (Nutraflora scFOS) |
| Osmolite | Active comparator | Other: Osmolitenon-prebiotic fiber containing formula (Osmolite) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult major neurological injury trauma patients between 18-70 years of age who have been admitted directly to trauma ICU following major trauma
- Expected length of mechanical ventilation > 48 hours (as judged by admitting clinician)
- Expected length of ICU stay > 3 days (as judged by admitting clinician)
- Expected to survive > 48 hours (as judged by admitting clinician)
- Requiring enteral nutrition at any time in Intensive Care Unit (ICU) stay
Key exclusion criteria (9 listed)
- Previous hospitalization within one month prior to ICU admission (no hospital floor transfers to eliminate confounding effect of previous hospital therapy)
- Use of prebiotic fiber containing enteral or oral formula or probiotic preparations within one week
- Received antibiotics within the previous month
- On steroids or immunosuppressants at time of admission
- All transplant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutraflora scFOSprebiotic fiber (Nutraflora scFOS via Vital AF) | Other | Nutraflora scFOS |
| Osmolitenon-prebiotic fiber containing formula (Osmolite) | Other | Osmolite |
Primary outcome
Changes in microbiome
Time frame: Baseline (within 48 hours of ICU admission), up to 10 days
Stool samples
Overall microbiome composition sampling gut
Time frame: Baseline (within 48 hours of ICU admission), up to 10 days
Stool samples
Change in microbiome longitudinally
Time frame: Baseline at Day 2, 4, 6, 8 and 10
Tongue swab microbiome longitudinally
Changes in the microbiome on delivery of initial clinical outcomes in trauma patients
Time frame: Baseline (within 48 hours of ICU admission), up to 10 days
Stool samples
4 secondary outcomes
Record length of mechanical ventilation
Time frame: Up to 60 days
Length of ICU
Time frame: Up to 60 days
Length of hospital stay
Time frame: Up to 60 days
Mortality
Time frame: Up to 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Derived from this study: PubMed 41462238Serbanescu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Wischmeyer, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutraflora scFOS and Osmolite in people with Enteral Nutrition and Brain Injuries, Traumatic, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in microbiome (time frame: Baseline (within 48 hours of ICU admission), up to 10 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03153397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.