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Simple stool test may predict deadly gut disease in preemies

NCT ID NCT02010268

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 1 time

Summary

This study looked at whether a simple stool test could help predict serious gut inflammation in premature babies. Researchers collected stool samples from 122 preterm infants born at 33 weeks or less, testing for a protein called calprotectin. The goal was to see if this test, combined with other factors, could create a score to warn doctors early about conditions like necrotizing enterocolitis.

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 simple stool test to predict dangerous gut problems in premature babies, allowing earlier treatment.
What could go wrong
This is a small, completed observational study, not a treatment trial. The score needs much more testing before it could be used in hospitals.

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

122 people

The number who actually took part.

Started

Sep 2013

Finished

Feb 2015

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

Up to 33 months

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: * Infants prematurely born at a gestational age of 33 weeks or less (or before the 7th month of pregnancy). * Patient whose parents or holders of parental authority signed an informed consent. Exclusion Criteria: * Patient with a malformation. * Lack of signature of the consent by parents or holders of parental authority.

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Conditions

The condition(s) this trial relates to.

enterocolitis intestinal disorder necrotizing enterocolitis

As listed by the trial registrant

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

Enteropathy, necrotizing enterocolitis

Contacts and locations

Locations

  • Necker Hospital

    Paris, 75015, France