Could a special formula prevent gut trouble after brain injury?

NCT ID NCT07092423

Symptom relief Sponsor: Tang-Du Hospital Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a semi-elemental liquid diet (a pre-digested formula) reduces stomach and bowel issues like vomiting, diarrhea, and bloating in patients with severe traumatic brain injury. About 100 adults will receive either the special formula or standard liquid nutrition for at least 7 days. The goal is to see if the special diet is better tolerated and may lead to shorter hospital stays.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: semi-elemental formula (a special liquid diet)
What this could lead to: If it works, this could point toward a better way to feed brain injury patients with fewer digestive side effects.
What could go wrong: This is a small, early exploratory study (100 people) looking at short-term tolerance, not survival or recovery. The results may not apply to all brain injury patients.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Enteral feeding intolerance Neurocritical care Traumatic brain injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could a special formula prevent gut trouble after brain injury?

What the study statuses mean