NCT07092423

Effect of Semi-elemental Enteral Nutrition on Gastrointestinal Tolerance in Patients With Traumatic Brain Injury.

The Effect of Semi-elemental Enteral Nutrition on Gastrointestinal Tolerance in Patients With Traumatic Brain Injury: a Randomized Exploratory Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Background: Patients with traumatic brain injury (TBI) frequently exhibit gastrointestinal dysfunction secondary to central nervous system impairment. This dysregulation impairs nutrient absorption, exacerbates systemic inflammation, and compromises clinical recovery trajectories. Emerging evidence suggests that semi-elemental enteral nutrition (SEN)-featuring hydrolyzed macronutrients with low-osmolality formulations-may mitigate these sequelae by reducing digestive burden and enhancing mucosal healing. However, robust clinical evidence supporting its superiority over standard enteral feeding in severe TBI populations remains limited. Objectives: Primary Objective: To evaluate the efficacy of semi-elemental enteral nutrition (SEN) in improving gastrointestinal tolerance during the acute phase (first 7 days post-injury) in patients with severe traumatic brain injury (TBI). Secondary Objectives: 1. To assess gastrointestinal complications within 7 days of enteral nutrition initiation, including: Incidence of diarrhea and diarrhea-free days Incidence of constipation Incidence of vomiting Incidence of gastroparesis Incidence of abdominal distension Time to first onset of gastrointestinal intolerance symptoms Duration of gastrointestinal intolerance symptoms 2. To evaluate clinical outcomes: Hospitalization duration (total and ICU-specific) 6-month mortality and functional recovery 3. To determine safety profiles: Infection rates Pneumonia incidence Other adverse events Study Design: A multicenter, randomized, double-blind, parallel-group exploratery trial will be conducted. 100 severe TBI patients will be allocated 1:1 to intervention (SEN formula) or control (standard formula) arms within 48 hours of injury.

Conditions

• Traumatic Brain Injury
• Neurocritical Care
• Enteral Feeding Intolerance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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

Timeline

• Start date: 2025-05-18
• Primary completion: 2026-11-18
• Completion: 2027-05-31
• First posted: 2025-07-29
• Last updated: 2025-07-29

Locations

1 site across 1 country: China