Actively Recruiting
Effect of Semi-elemental Enteral Nutrition on Gastrointestinal Tolerance in Patients With Traumatic Brain Injury.
Led by Tang-Du Hospital · Updated on 2026-04-30
100
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
Sponsors
T
Tang-Du Hospital
Lead Sponsor
A
Ankang Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Semi-elemental Enteral Nutrition on Gastrointestinal Tolerance in Patients With Traumatic Brain Injury.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-75 years
- Diagnosed with closed traumatic brain injury
- Glasgow Coma Scale score of 8 or less
- Able to start enteral nutrition within 48 hours after injury
- Expected to need enteral nutrition for at least 3 days with Nutritional Risk Screening 2002 score of 3 or higher
You will not qualify if you...
- Glasgow Coma Scale score of 3 with both pupils fixed and dilated
- Hemodynamic instability or respiratory failure with defined abnormal blood pressure, oxygen, carbon dioxide, or lactate levels
- Cannot place nasogastric or nasojejunal feeding tube within 48 hours
- Contraindications to enteral nutrition or semi-recumbent positioning
- Pre-existing intellectual or physical disability affecting assessment
- Gastrointestinal abnormalities affecting function like short bowel syndrome, ulcerative colitis, Crohn's disease, or ostomy
- Body mass index below 18 kg/m2
- Abdominal or extracranial injury with AIS score over 3
- Malignancy, severe heart, liver, or kidney failure at ICU admission
- Other severe diseases with expected survival less than 14 days
- Pregnancy, within 30 days postpartum, or breastfeeding
- Refusal of treatment or receiving palliative care
- Patient or family declines consent
- Currently in another interventional clinical trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tangdu Hospital
Xi'an, Shaanxi, China, 710038
Actively Recruiting
Research Team
H
Haixiao Liu, MD, PhD
CONTACT
H
Hao Guo, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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