Effect of Semi-elemental Enteral Nutrition on Gastrointestinal Tolerance in Patients With Traumatic Brain Injury.
Condition(s) studied
Investigational drug(s) / intervention(s)
Semi-elemental formula: Treatment: Semi-elemental enteral nutrition Objective: To assess the efficacy of semi-elemental enteral nutrition in enhancing gastrointestinal tolerance in patients with severe traumatic brain injury.
Standard formula: Treatment: Standard enteral nutrition Objective: To serve as the control for evaluating the efficacy and safety of semi-elemental enteral nutrition versus standard nutritional therapy
Study summary
Study Objective This clinical trial primarily aims to investigate whether semi-elemental enteral nutrition (SEN) improves gastrointestinal tolerance in patients with severe traumatic brain injury (TBI) and to evaluate its impact on clinical outcomes. The safety profile of SEN will also be assessed.
Key Research Questions Does SEN reduce the incidence of acute gastrointestinal injury (AGI) in severe TBI patients?
Study Design
Participants will be randomized 1:1 into either:
Intervention group: Receives SEN initiated within 48 hours post-injury and continued for ≥7 days.
Control group: Receives standard enteral nutrition over the same period.
Eligibility
Primary outcome measure(s)
- Incidence of Gastrointestinal Intolerance — Within 7 days.
Proportion of patients developing gastrointestinal intolerance within 7 days of enteral nutrition initiation. (Composite endpoint including: vomiting, diarrhea, constipation, gastroparesis, gastrointestinal bleeding, and abdominal distension.)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Tangdu Hospital | Xi'an | Shaanxi | Recruiting |
More Tang-Du Hospital trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07092423 on ClinicalTrials.gov ↗ ← All trials in China