Ireland
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Recruiting Not applicable

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

NCT07092423 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-05-18
Last updated
2026-04-30

Condition(s) studied

Traumatic Brain InjuryNeurocritical CareEnteral Feeding Intolerance

Investigational drug(s) / intervention(s)

Semi-elemental formulaStandard formula

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Aged 18-75 years; * Clinically diagnosed with closed traumatic brain injury; * Glasgow Coma Scale (GCS) score ≤ 8; * Ability to initiate enteral nutrition within 48 hours post-injury; * Expected need for enteral nutrition support ≥3 days based on clinical assessment (Nutritional Risk Screening 2002 \[NRS2002\] score ≥3). Exclusion Criteria: * GCS=3 with bilateral fixed and dilated pupils; * Hemodynamic instability or respiratory failure: mean arterial pressure \<70mmHg, PaO2/FiO2\<150, PaCO2\<30 mmHg or \>45 mmHg, or lactate \>5 mmol/l; * Contraindications to both nasogastric and nasojejunal tube placement, or inability to complete tube placement within 48 hours of onset; * Contraindications to enteral nutrition therapy or semi-recumbent positioning; * Pre-existing intellectual disability or physical disability affecting outcome assessment; * Gastrointestinal abnormalities likely to affect gastrointestinal function, such as short bowel syndrome (defined as total small bowel length ≤122 cm), ulcerative colitis, Crohn's disease, or any form of ostomy; * Body mass index (BMI) \<18kg/m2; * Concomitant abdominal injury or extracranial injury with AIS score \>3 in any region; * Presence of malignancy, severe cardiac insufficiency (ejection fraction \<50%), severe hepatic failure (Child-Pugh score ≥7), or severe renal failure (glomerular filtration rate ≤30 mL/min or serum creatinine ≥4mg/dL) at NICU admission; * Concurrent severe disease with expected survival ≤14 days; * Pregnancy, within 30 days postpartum, or breastfeeding; * Refusal of treatment or receipt of palliative care; * Patient or family declines informed consent; * Current participation in another interventional clinical trial.

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)

FacilityCityRegionStatus
Tangdu Hospital Xi'an Shaanxi Recruiting
Official registry record

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