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Gut bacteria clues could help predict dangerous bowel disease in preemies

NCT ID NCT04972734

Knowledge-focused Sponsor: University Hospital, Clermont-Ferrand 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study looks at the gut bacteria of premature babies to see if differences exist between those who develop necrotizing enterocolitis (NEC) — a severe bowel condition — and those who do not. Researchers collect weekly blood and daily stool samples from about 300 premature infants over 12 weeks. The goal is to better understand the role of gut microbes in NEC, which could eventually help with early detection or prevention.

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 differences in gut bacteria are found, this could lead to earlier detection or prevention of NEC in premature babies.
What could go wrong
This is an observational study, not a treatment trial. It may not identify clear bacterial patterns, and any findings will need further research to become useful.

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

297 people

The number who actually took part.

Started

Jul 2021

Finished

Jun 2026

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

1 minute to 2 minutes

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: * born prematurely \< 37 weeks of amenorrhea at the maternity ward of the CHU * affiliated with a social security regime * the holders of parental authority are able to give an informed consent to participate in the research Exclusion Criteria: * fetal pathology * newborns whose holders of parental authority are under guardianship or under the age of 18 * refusal of participation by holders of parental authority

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Conditions

The condition(s) this trial relates to.

necrotizing enterocolitis Premature Birth

As listed by the trial registrant

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

Necrotizing enterocolitis Premature birth

Contacts and locations

Locations

  • CHU Clermont-Ferrand

    Clermont-Ferrand, France

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