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

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.

Conditions

• Traumatic Brain Injury
• Neurocritical Care
• Enteral Feeding Intolerance

Interventions

DIETARY_SUPPLEMENT

Standard formula

Treatment: Standard enteral nutrition Objective: To serve as the control for evaluating the efficacy and safety of semi-elemental enteral nutrition versus standard nutritional therapy

DIETARY_SUPPLEMENT

Semi-elemental formula

Treatment: Semi-elemental enteral nutrition Objective: To assess the efficacy of semi-elemental enteral nutrition in enhancing gastrointestinal tolerance in patients with severe traumatic brain injury.

Sponsors & Collaborators

• Ankang Central Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University (Qingdao)

  collaborator OTHER

• 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China

  collaborator OTHER

• 904th Hospital of the Joint Logistics Support Force of the PLA

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Qianfoshan Hospital

  collaborator OTHER

• The First Affiliated Hospital of Xinxiang Medical College

  collaborator OTHER

• Hanzhong Central Hospital

  collaborator OTHER

• The General Hospital of Western Theater Command

  collaborator OTHER

• The General Hospital of Northern Theater Command

  collaborator OTHER

• Tangshan Gongren Hospital

  collaborator OTHER

• 987th Hospital of the Chinese People's Liberation Army Joint Logistic Support Force

  collaborator OTHER

• Tang-Du Hospital

  lead OTHER

Principal Investigators

• Yan Qu, MD, PhD · Tang-Du Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-18

Primary Completion

2026-11-18

Completion

2027-05-31

Countries

• China

Study Locations