Predictive model may personalize ICU feeding to cut intolerance

NCT ID NCT06827275

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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)
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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
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Status unknown
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First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial tests whether a modified feeding protocol, guided by a predictive model of feeding intolerance, can reduce digestive problems in critically ill patients. The study will enroll 2,250 adults in ICUs across 90 hospitals, with each hospital randomly assigned to use the new protocol or standard care. The goal is to see if personalizing nutrition delivery based on predicted intolerance helps patients meet their nutritional needs while avoiding issues like vomiting, diarrhea, or high stomach residue.

What this could mean

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

Active substance
A modified feeding protocol for critically ill patients, guided by a predictive model of feeding intolerance
What this could lead to
If successful, this approach could reduce feeding intolerance and improve nutrition delivery for critically ill patients in ICUs, potentially leading to better recovery outcomes.
What could go wrong
This is an early-stage trial, and the intervention is a protocol change rather than a drug, so benefits may be modest or hard to measure across diverse ICU settings. There is also a risk of gastrointestinal complications, though these are managed symptomatically.

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 2,250 people

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

Started

Feb 2025

Expected to finish

Dec 2026

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 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: Age 18 or older Failure of one or more organ systems within 24 hours of admission to the ICU (SOFA score ≥2) Expected to stay in ICU for more than 48 hours Inability to eat orally No EN taboo ICU Selection Criteria: ICU in Grade 2 or above hospitals ICU with the ability to carry out intensive care and monitor patient FI ICU type: emergency, medical, surgical, neurosurgical, or comprehensive ICU Exclusion Criteria: Patients who have received EN treatment in the past three days AGI Level IV patients Receiving palliative care and expected to die within 48 hours Pregnancy Long-term use of steroids or other immunosuppressants Patients undergoing radiotherapy or chemotherapy for malignant diseases Participation in other clinical studies ICU Exclusion Criteria: ICU that refuses to participate in the study ICU that has not passed the ethical review Pediatric ICU

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As listed by the trial registrant

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

How to take part

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  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

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Contacts and locations

Locations

  • Jilin University, Chaoyang District, Changchun City, Jilin Province

    NOT_YET_RECRUITING

    Changchun, Jilin, 130021, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130000, China

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