Actively Recruiting
Effect of Semi-elemental Enteral Nutrition on Gastrointestinal Tolerance in Patients With Traumatic Brain Injury: a Randomized Exploratory Study
Led by Tang-Du Hospital · Updated on 2026-04-30
100
Participants Needed
1
Research Sites
27 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
This research aims to evaluate whether semi-elemental enteral nutrition (SEN) improves gastrointestinal tolerance in patients with severe traumatic brain injury (TBI). The trial investigates if SEN can reduce acute gastrointestinal injury compared to standard enteral nutrition, while also assessing the safety profile and clinical outcomes such as hospitalization length, mortality, and functional recovery. The study is a randomized, double-blind, parallel-group exploratory trial involving severe TBI patients. Participants will be randomly assigned to one of two groups: the intervention group receiving semi-elemental enteral nutrition started within 48 hours after injury and continued for at least 7 days, and the control group receiving standard enteral nutrition for the same duration. Both treatments involve enteral feeding formulas designed to support nutrition in critically ill TBI patients. During the study, participants will be monitored for gastrointestinal tolerance over the first 7 days, including symptoms like diarrhea, vomiting, and abdominal distension. Researchers will also assess hospitalization times, infection rates, mortality up to six months, and functional outcomes. The trial includes safety monitoring and collects data on adverse events. Overall participation spans from the acute phase through 6 months for follow-up outcomes.
CONDITIONS
Brief 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 to 75 years
- Clinically diagnosed with closed traumatic brain injury
- Glasgow Coma Scale (GCS) score 8 or less
- Ability to start enteral nutrition within 48 hours after injury
- Expected need for enteral nutrition support for at least 3 days based on clinical assessment (NRS2002 score 3 or higher)
You will not qualify if you...
- Glasgow Coma Scale score 3 with bilateral fixed and dilated pupils
- Hemodynamic instability or respiratory failure (mean arterial pressure below 70 mmHg, PaO2/FiO2 ratio below 150, PaCO2 below 30 mmHg or above 45 mmHg, or lactate above 5 mmol/l)
- Contraindications to nasogastric or nasojejunal tube placement or inability to complete tube placement within 48 hours
- Contraindications to enteral nutrition or semi-recumbent positioning
- Pre-existing intellectual or physical disabilities affecting outcome assessment
- Gastrointestinal abnormalities affecting function such as short bowel syndrome, ulcerative colitis, Crohn's disease, or any ostomy
- Body mass index below 18 kg/m2
- Concomitant abdominal or extracranial injury with AIS score above 3
- Presence of malignancy, severe cardiac insufficiency (ejection fraction below 50%), severe hepatic failure (Child-Pugh score 7 or higher), or severe renal failure (GFR 30 mL/min or less or serum creatinine 4 mg/dL or higher) at NICU admission
- Concurrent severe disease with expected survival 14 days or less
- 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
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 2 days after injury
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 7 days
Participants receive either semi-elemental or standard enteral nutrition to support gastrointestinal tolerance during the acute phase of traumatic brain injury.
Daily visits during enteral nutrition administration
Duration - Up to 6 months
Participants are monitored for hospitalization outcomes, mortality, functional recovery, and safety events after the treatment period.
Periodic assessments during hospitalization and follow-up visits up to 6 months
Trial Site Locations
Total: 1 location
1
Tangdu Hospital
Xi'an, Shaanxi, China, 710038
Actively Recruiting
Research Team
H
Haixiao Liu, MD, PhD
H
Hao Guo, MD, PhD
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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