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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
China
Tangdu Hospital
RECRUITING
Xi'an
Contact Information
Primary
Haixiao Liu, MD, PhD
hai_xiao_liu@163.com
+86-029-84717556
Backup
Hao Guo, MD, PhD
guohao0622@163.com
+86-029-84717556
Time Frame
Start Date: 2025-05-18
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 100
Treatments
Experimental: Intervention Group
Patients will receive semi-elemental enteral nutrition.
Active_comparator: Control Group
Patients will receive standard enteral nutrition.
Related Therapeutic Areas
Sponsors
Leads: Tang-Du Hospital

This content was sourced from clinicaltrials.gov