RecruitingNot ApplicableNCT07092423

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

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


Sponsor

Tang-Du Hospital

Enrollment

100 participants

Start Date

May 18, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Semi-elemental formula and Standard formula for people with enteral feeding intolerance, neurocritical care, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTSemi-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.

DIETARY_SUPPLEMENTStandard 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


Locations(1)

Tangdu Hospital

Xi'an, Shaanxi, China

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NCT07092423


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