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Premature Babies' gut bugs linked to future immunity

NCT ID NCT02738411

Knowledge-focused Sponsor: Centre Hospitalier Universitaire de Nīmes 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This study looks at how the types of bacteria in the guts of premature babies during their first six weeks of life might affect their immune system at age 3. Researchers will track 130 preterm infants born before 33 weeks to see if early gut changes are linked to a balanced immune response. The goal is to better understand early development, not to test a treatment.

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

130 people

The number who actually took part.

Started

May 2017

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.

Who is studied

The study population consists of premature babies born at \< 33 months gestation.

Ages

Up to 1 day

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: * The parents of the patient (or legal guardian if any) have been informed about the implementation of the study, its objectives, its constraints, and patient rights * The parents of the patient (or legal guardian if any) must have given their free and informed consent and signed the consent form * The patient must be affiliated with or beneficiary of a health insurance plan * Premature infants born at less than 33 weeks of gestation Exclusion Criteria: * The patient is participating in another interventional study (Excepted " Recherche du Portage de Clostridium butyricum et de Toxines de Clostridium chez les Prématurés Hospitalisés en Néonatologie afin de prédire la survenue d'Entérocolites Nécrosantes", RCB 2016-A00-529-42 ; " BetaDose Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth ", RCB 2016-001486-90. * It is not possible to correctly inform the parent (or legal guardian, if applicable) * A serious deformity or digestive malformation was diagnosed at birth * During the hospital stay in the neonatology department, the patient had a digestive disease requiring surgery (except necrotizing enterocolitis) * A transfer to another hospital is foreseen/predictable (eg, due to geographical distance)

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

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

Infant, premature

Contacts and locations

Locations

  • CHRU de Montpellier - Hôpital Arnaud de Villeneuve

    Montpellier, 34295, France

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029, France

  • Réseau GRANDIR EN LANGUEDOC-ROUSILLON

    Saint-Gély-du-Fesc, 34980, France

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