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Can tailored nutrition boost recovery in the ICU?

NCT ID NCT07755033

Disease control Sponsor: Chinese Medical Association Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial investigates whether a nutrition formula customized daily to each patient's measured energy needs and protein levels can improve outcomes for critically ill adults in the intensive care unit (ICU), including those with sepsis. Participants are randomly assigned to receive either this individualized formula or a standard fixed-dose formula for up to 14 days. Researchers will track length of ICU stay and changes in gut and lung bacteria, blood chemistry, and nutrient balance to see if personalized feeding offers advantages over routine care.

What this could mean

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

Active substance
Individualized enteral nutrition formula based on daily metabolic measurements
What this could lead to
If effective, this approach could establish personalized nutrition as a standard ICU strategy, potentially reducing complications and improving recovery in critically ill patients.
What could go wrong
The trial is early and complex, and the benefits of individualized feeding over standard care remain unproven. Results may vary widely among critically ill patients, and the intervention's complexity could limit real-world use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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 1,200 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

18 years and older

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: Critically ill patients admitted to the intensive care unit (ICU) who meet the indications for enteral nutrition support. Age ≥ 18 years. APACHE II score \> 8 at ICU admission. Expected ICU length of stay \> 7 days. Exclusion Criteria: Age \< 18 years. Pregnancy or lactation. Known allergy to any component of the enteral nutrition formula. Gastrointestinal bleeding, incomplete intestinal obstruction, or other conditions precluding full enteral nutrition. Known severe thyroid dysfunction (e.g., thyrotoxic crisis, myxedema coma, or uncontrolled hyperthyroidism/hypothyroidism). Chronic end-stage organ failure, including: New York Heart Association (NYHA) Class IV heart failure, Child-Pugh Class C cirrhosis, or Stage 5 chronic kidney disease (CKD). Primary intestinal diseases (e.g., Crohn's disease, ulcerative colitis, or intestinal malignancies), short bowel syndrome, or history of extensive small bowel resection (residual small intestine \< 100 cm). Metabolic disorders that significantly affect nutritional metabolism (e.g., Sheehan's syndrome, or other conditions with major metabolic consequences) as determined by the investigator.

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Conditions

The condition(s) this trial relates to.

Critical Illness infectious disease with sepsis nutritional disorder Sepsis

As listed by the trial registrant

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

Gut microbiota Nutrition Sepsis

How to take part

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

  1. The official record

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

    Open the record ↗

  2. A doctor treating you

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