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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutraflora scFOS | Experimental | prebiotic fiber-containing formula (Nutraflora scFOS) |
|
| Osmolite | Active Comparator | non-prebiotic fiber containing formula (Osmolite) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutraflora scFOS | Other | prebiotic fiber (Nutraflora scFOS via Vital AF) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Record length of mechanical ventilation | Up to 60 days | |
| Length of ICU | Up to 60 days | |
| Length of hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Wischmeyer, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41462238 | Derived | 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. |
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| Osmolite |
| Other |
non-prebiotic fiber containing formula (Osmolite) |
|
| Up to 60 days |
| Mortality | Up to 60 days |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C080652 | Osmolite |
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