A sip of food dye may expose a hidden gut leak linked to ICU survival
NCT ID NCT06845865
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This study tests whether a simple oral food dye can measure intestinal permeability in intensive care patients with organ failure. Researchers will give patients a small dose of dye and track how much appears in the blood, then compare that with survival at 90 days. The goal is to see if a leaky gut, which may allow bacteria to enter the bloodstream, is linked to worse outcomes. The trial enrolls about 126 ICU patients with single or multiple organ failure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an oral food coloring dye solution
- What this could lead to
- If increased intestinal permeability predicts worse survival, doctors could use this simple dye test to identify high-risk ICU patients earlier and guide treatment.
- What could go wrong
- This is an observational measurement study, not a treatment trial, so it cannot change outcomes directly. The dye test may not reliably reflect gut barrier function in all patients, and results may not generalize beyond this specific ICU population.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 126 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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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
hosptalized adults in ICU, France.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: Patient with single organ failure, secondary to sepsis, hospitalized in intensive care for a foreseeable duration of \> 48 hours * SAPS2 between 20 and 40 at the sixth hour after the diagnosis of organ failure. * Consent from the patient or their trusted person. * Affiliation to a social security system. * Functional digestive tract and possible feeding (per os or via a nasogastric tube whose indication was determined independently of the study's needs). Second group of patients with multi-organ failure: * Multi-organ failure syndrome with at least 2 organ failures, secondary to sepsis. * SAPS2 between 60 and 80 at the sixth hour after the diagnosis of organ failure. * Consent from the patient or their trusted person. * Affiliation to a social security system. * Functional digestive tract and possible feeding (conscious patient able to swallow or with a nasogastric tube whose indication was determined independently of the study's needs). Exclusion Criteria: * Pregnant and breastfeeding women; * Minors; * Persons under administrative and judicial supervision; * Absence of a functional digestive tract (patient unable to swallow and absence of a nasogastric tube, contraindication to enteral feeding); * Patients with gastroparesis; * Refusal of the patient or their trusted person; * Patient with a SAPS2 at the sixth hour after the diagnosis of organ failure \< 20 or between 40 and 60 or \> 80.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Hopital Bégin
RECRUITINGVincennes, France
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