Semi-elemental tube feeding to improve gut tolerance after severe traumatic brain injury

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

This will test whether starting semi-elemental tube feeding within 48 hours reduces gastrointestinal intolerance in adults with severe traumatic brain injury.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tang-Du Hospital (Academic / other)
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT07092423 on ClinicalTrials.gov

What this trial studies

Adults with severe closed TBI (GCS ≤8) who can start enteral nutrition within 48 hours will be randomized 1:1 to receive either a semi-elemental enteral formula or standard enteral nutrition. The assigned feeding is continued for at least seven days while patients are monitored during the acute phase. The primary outcome is gastrointestinal tolerance in the first seven days; secondary outcomes include specific GI complications (diarrhea, vomiting, gastroparesis, abdominal distension), ICU and hospital length of stay, six-month mortality and functional recovery, and safety events such as infections. The trial tests whether a hydrolyzed, low-osmolality formula reduces digestive burden and improves mucosal function and clinical recovery compared with standard feeding.

Who should consider this trial

Good fit: Adults aged 18–75 with closed severe TBI (GCS ≤8) who can initiate enteral nutrition within 48 hours and are expected to need feeding for at least three days.

Not a fit: Patients with contraindications to enteral feeding or tube placement, significant hemodynamic or respiratory instability, major pre-existing GI disorders, or brain death (GCS 3 with bilaterally fixed dilated pupils) are unlikely to benefit.

Why it matters

Potential benefit: If successful, semi-elemental feeding could reduce early gastrointestinal complications, improve nutrient delivery, and support recovery after severe TBI.

How similar studies have performed: Some smaller or indirect studies in critically ill populations suggest semi-elemental formulas may improve tolerance, but robust randomized evidence specifically in severe TBI is limited.

Eligibility criteria

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.

Where this trial is running

Xi'an, Shaanxi

• Tangdu Hospital — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Study coordinator: Haixiao Liu, MD, PhD

Conditions Traumatic Brain Injury; Neurocritical Care; Enteral Feeding Intolerance; Enteral Nutrition; Gastrointestinal Intolerance; Semi-elemental Formula; Prognosis