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New gut damage test could help ICU doctors spot hidden injury

NCT ID NCT07440368

Knowledge-focused Sponsor: The First Hospital of Jilin University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at a protein called I-FABP, which is released when gut cells are damaged. Researchers will measure it in the blood and urine of 500 ICU patients to see if it relates to how severe their gastrointestinal problems are. No treatments are given—this is purely to gather information and improve how doctors assess gut health in critical illness.

What this could mean

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

What this could lead to
If successful, this could lead to a more objective way to diagnose and grade gut injury in critically ill patients, improving care.
What could go wrong
This is an observational study, so it won't test any treatment. The biomarker may not prove useful in real-world settings.

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.

Participants

About 500 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

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.

Who is studied

This prospective observational cohort will consecutively enroll adult critically ill patients (≥18 years) admitted to the ICU with an expected ICU stay of at least 48 hours. Paired plasma and urine samples will be collected within 24 hours of ICU admission (and repeated on ICU day 3) to measure intestinal fatty acid-binding protein (I-FABP). Gastrointestinal function will be assessed daily during ICU stay to grade acute gastrointestinal injury (AGI) according to the ESICM definition. Patients with pre-existing inflammatory bowel disease, short bowel syndrome, chronic intestinal failure requiring long-term parenteral nutrition, pregnancy, or those who refuse/withdraw consent will be excluded.

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: * 1、 Age ≥18 years. * 2 、Admission to the ICU with an expected ICU stay ≥48 hours. * 3 、Availability of paired plasma and urine samples within 24 hours of ICU admission. * 4 、Feasible daily gastrointestinal function assessment to complete AGI grading (ESICM definition). Exclusion Criteria: * 1、 Pre-existing inflammatory bowel disease. * 2 、Short bowel syndrome. * 3、 Chronic intestinal failure requiring long-term parenteral nutrition. * 4、 Pregnancy. * 5 、Refusal or withdrawal of informed consent.

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Conditions

The condition(s) this trial relates to.

Critical Illness

As listed by the trial registrant

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

Adult Expected hospital stay ≥48 hours Patients admitted to the icu

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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More trials for these conditions

Other studies related to the condition(s) this trial covers.