Traumatic Brain InjurySEMINARNCT07092423
Effect of Semi-elemental Enteral Nutrition on Gastrointestinal Tolerance in Patients With Traumatic Brain Injury.
A study testing Semi-elemental formula and Standard formula in people with Traumatic Brain Injury and Neurocritical Care, run by Tang-Du Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Traumatic Brain Injury, Neurocritical Care, Enteral Feeding Intolerance
- What is being tested?
- Semi-elemental formula and Standard formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tangdu Hospital
Xi'an, Shaanxi, 710038
Haixiao Liu, PhD, MD, +86-02984778359, lhxiao@fmmu.edu.cn
Yan Qu, PhD, MD
About this study
Official title: The Effect of Semi-elemental Enteral Nutrition on Gastrointestinal Tolerance in Patients With Traumatic Brain Injury: a Randomized Exploratory Study
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.
Read the detailed description
Background:
Patients with traumatic brain injury (TBI) frequently exhibit gastrointestinal dysfunction secondary to central nervous system impairment. This dysregulation impairs nutrient absorption, exacerbates systemic inflammation, and compromises clinical recovery trajectories. Emerging evidence suggests that semi-elemental enteral nutrition (SEN)-featuring hydrolyzed macronutrients with low-osmolality formulations-may mitigate these sequelae by reducing digestive burden and enhancing mucosal healing. However, robust clinical evidence supporting its superiority over standard enteral feeding in severe TBI populations remains limited.
Objectives:
Primary Objective:
To evaluate the efficacy of semi-elemental enteral nutrition (SEN) in improving gastrointestinal tolerance during the acute phase (first 7 days post-injury) in patients with severe traumatic brain injury (TBI).
Secondary Objectives:
- To assess gastrointestinal complications within 7 days of enteral nutrition initiation, including: Incidence of diarrhea and diarrhea-free days Incidence of constipation Incidence of vomiting Incidence of gastroparesis Incidence of abdominal distension Time to first onset of gastrointestinal intolerance symptoms Duration of gastrointestinal intolerance symptoms
- To evaluate clinical outcomes: Hospitalization duration (total and ICU-specific) 6-month mortality and functional recovery
- To determine safety profiles:
Infection rates Pneumonia incidence Other adverse events
Study Design:
A multicenter, randomized, double-blind, parallel-group exploratery trial will be conducted. 100 severe TBI patients will be allocated 1:1 to intervention (SEN formula) or control (standard formula) arms within 48 hours of injury.
- Being tested
- Semi-elemental formula, Standard formula
- Keywords
- Traumatic Brain Injury, Enteral Nutrition, Gastrointestinal Intolerance, Semi-elemental Formula, Neurocritical Care, Prognosis
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients will receive semi-elemental enteral nutrition. Receives: Dietary Supplement: Semi-elemental formula |
| Control Group | Active comparator | Patients will receive standard enteral nutrition. Receives: Dietary Supplement: Standard formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: Within 7 days.
Secondary outcomes (10)
Hospitalization length of stay (LOS)
Total length of stay in the hospital.
Measured: Periprocedural.
NICU LOS
Total length of stay in the neurological intensive care unit (NICU)
Measured: Periprocedural
In-hospital mortality
Mortality rate in hospital.
Measured: Periprocedural.
ICU mortality
Mortality rate in NICU
Measured: Periprocedural
Three-month mortality
Mortality rate at 3-month.
Measured: Within 3 months.
Six-month mortality
Mortality rate at 6-month.
Measured: Within 6 months.
Functional outcomes (GOSE)
The Glasgow Outcome Scale-Extended (GOSE) scores at 3 and 6 months. The score ranges from 1 to 8, with higher scores indicating a better outcome.
Measured: Within 6 months.
Functional outcomes (Barthel)
The Barthel Index scores at 3 and 6 months.The score ranges from 1 to 100, with higher scores indicating a better outcome.
Measured: Within 6 months.
Gastrointestinal intolerance events
Gastrointestinal intolerance events within 7 days of enteral nutrition initiation, including:
- Incidence of diarrhea.
- Diarrhea-free days.
- Incidence of constipation.
- Incidence of vomiting.
- Incidence of gastroparesis.
- Incidence of abdominal distension.
- Time to first onset of symptoms.
- Symptom duration.
Measured: Within 7 days.
Infection
Infection rate during 14-day period (or throughout hospitalization if discharged earlier).
Measured: Within 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start18 May 2025
- Primary completion18 Nov 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Yan Qu, MD, PhD, Study chair, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092423
- Sponsor's protocol ID
- SEMINAR Study
- Acronym
- SEMINAR
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will be determined in accordance with sponsor requirements.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Semi-elemental Enteral Nutrition on Gastrointestinal Tolerance in Patients With Traumatic Brain Injury: a Randomized Exploratory Study
- ClinicalTrials.gov ID
- NCT07092423
- Acronym / sponsor ID
- SEMINAR / SEMINAR Study
- Keywords
- Traumatic Brain Injury, Enteral Nutrition, Gastrointestinal Intolerance, Semi-elemental Formula, Neurocritical Care, Prognosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- 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
- Study start
- 18 May 2025 (actual)
- Primary completion
- 18 Nov 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Patients with traumatic brain injury (TBI) frequently exhibit gastrointestinal dysfunction secondary to central nervous system impairment. This dysregulation impairs nutrient absorption, exacerbates systemic inflammation, and compromises clinical recovery trajectories. Emerging evidence suggests that semi-elemental enteral nutrition (SEN)-featuring hydrolyzed macronutrients with low-osmolality formulations-may mitigate these sequelae by reducing digestive burden and enhancing mucosal healing. However, robust clinical evidence supporting its superiority over standard enteral feeding in severe TBI populations remains limited.
Objectives:
Primary Objective:
To evaluate the efficacy of semi-elemental enteral nutrition (SEN) in improving gastrointestinal tolerance during the acute phase (first 7 days post-injury) in patients with severe traumatic brain injury (TBI).
Secondary Objectives:
- To assess gastrointestinal complications within 7 days of enteral nutrition initiation, including: Incidence of diarrhea and diarrhea-free days Incidence of constipation Incidence of vomiting Incidence of gastroparesis Incidence of abdominal distension Time to first onset of gastrointestinal intolerance symptoms Duration of gastrointestinal intolerance symptoms
- To evaluate clinical outcomes: Hospitalization duration (total and ICU-specific) 6-month mortality and functional recovery
- To determine safety profiles:
Infection rates Pneumonia incidence Other adverse events
Study Design:
A multicenter, randomized, double-blind, parallel-group exploratery trial will be conducted. 100 severe TBI patients will be allocated 1:1 to intervention (SEN formula) or control (standard formula) arms within 48 hours of injury.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Semi-elemental formulaPatients will receive semi-elemental enteral nutrition. |
| Control Group | Active comparator | Dietary Supplement: Standard formulaPatients will receive standard enteral nutrition. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-elemental formulaTreatment: 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 supplement | Intervention Group |
| Standard formulaTreatment: 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 | Control Group |
Primary outcome
Incidence of Gastrointestinal Intolerance
Time frame: Within 7 days.
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.)
10 secondary outcomes
Hospitalization length of stay (LOS)
Time frame: Periprocedural.
NICU LOS
Time frame: Periprocedural
In-hospital mortality
Time frame: Periprocedural.
ICU mortality
Time frame: Periprocedural
Three-month mortality
Time frame: Within 3 months.
Six-month mortality
Time frame: Within 6 months.
Functional outcomes (GOSE)
Time frame: Within 6 months.
Functional outcomes (Barthel)
Time frame: Within 6 months.
Gastrointestinal intolerance events
Time frame: Within 7 days.
Infection
Time frame: Within 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No. Will be determined in accordance with sponsor requirements.
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yan Qu, MD, PhD study chair
Tang-Du Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-elemental formula and Standard formula in people with Traumatic Brain Injury and Neurocritical Care, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haixiao Liu, MD, PhD (+86-029-84717556, hai_xiao_liu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Gastrointestinal Intolerance (time frame: Within 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.