NCT07092423

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
May 2025May 2027

First Submitted

Initial submission to the registry

April 11, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 18, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

April 11, 2025

Last Update Submit

April 26, 2026

Conditions

Neurocritical CareTraumatic Brain InjuryEnteral Feeding Intolerance

Keywords

Traumatic Brain InjuryEnteral NutritionGastrointestinal IntoleranceSemi-elemental FormulaNeurocritical CarePrognosis

Outcome Measures

Primary Outcomes (1)

  • Incidence of Gastrointestinal Intolerance

    Proportion of patients developing gastrointestinal intolerance within 7 days of enteral nutrition initiation. (Composite endpoint including: vomiting, diarrhea, constipation, gastroparesis, gastrointestinal bleeding, and abdominal distension.)

    Within 7 days.

Secondary Outcomes (10)

  • Hospitalization length of stay (LOS)

    Periprocedural.

  • NICU LOS

    Periprocedural

  • In-hospital mortality

    Periprocedural.

  • ICU mortality

    Periprocedural

  • Three-month mortality

    Within 3 months.

  • +5 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients will receive semi-elemental enteral nutrition.

Dietary Supplement: Semi-elemental formula

Control Group

ACTIVE COMPARATOR

Patients will receive standard enteral nutrition.

Dietary Supplement: Standard formula

Interventions

Semi-elemental formulaDIETARY_SUPPLEMENT

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.

Intervention Group
Standard formulaDIETARY_SUPPLEMENT

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

Control Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Yan Qu, MD, PhD

    Tang-Du Hospital

    STUDY CHAIR

Central Study Contacts

Haixiao Liu, MD, PhD

CONTACT

+86-029-84717556hai_xiao_liu@163.com

Hao Guo, MD, PhD

CONTACT

+86-029-84717556guohao0622@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2025

First Posted

July 29, 2025

Study Start

May 18, 2025

Primary Completion (Estimated)

November 18, 2026

Study Completion (Estimated)

May 31, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Will be determined in accordance with sponsor requirements.

Locations

CN(1)