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

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.

NCT Number	NCT07092423
Lead Sponsor	Tang-Du Hospital Collaborators: Ankang Central Hospital, Qilu Hospital of Shandong University (Qingdao), 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China, 904th Hospital of the Joint Logistics Support Force of the PLA, West China Hospital, Qianfoshan Hospital, The First Affiliated Hospital of Xinxiang Medical College, Hanzhong Central Hospital, The General Hospital of Western Theater Command, The General Hospital of Northern Theater Command, Tangshan Gongren Hospital, 987th Hospital of the Chinese People's Liberation Army Joint Logistic Support Force
Conditions	Traumatic Brain Injury, Neurocritical Care, Enteral Feeding Intolerance
Enrollment	100 participants
Start Date	2025-05-18
Primary Completion	2026-11-18 (estimated)
Study Completion	2027-05-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-30