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Gut germs for brain gains: probiotic trial aims to boost preterm baby development

NCT ID NCT07617181

Disease control Sponsor: Fudan 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving a daily probiotic mixture for 6 months can improve brain development in preterm infants who received antibiotics after birth. Researchers will enroll 116 babies and measure their developmental scores, gut bacteria changes, and inflammation markers. The goal is to see if remodeling the gut microbiome early in life leads to better neurodevelopmental outcomes.

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

About 116 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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.

Ages

23 to 25 weeks

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: * Preterm infants with a gestational age between 28 and 37 weeks (inclusive of 28 weeks) * Documented history of neonatal intravenous antibiotic exposure for at least 5 consecutive days during the neonatal period (e.g., in the NICU). * Corrected age of 6 months ± 7days at the time of enrollment. * No systemic antibiotic usage within 14 days prior to screening. * Legal guardians are willing to sign the informed consent form and comply with the 6-month intervention and follow-up schedule. Exclusion Criteria: * Severe congenital malformations, chromosomal abnormalities, or inherited metabolic diseases (e.g., Down syndrome). * Severe neurological disorders or structural brain injuries (e.g., Grade III/IV intraventricular hemorrhage, cystic periventricular leukomalacia, or hydrocephalus requiring a shunt). * Severe chronic diseases affecting growth and development (e.g., congenital heart disease requiring surgery, short bowel syndrome, or severe sequelae of necrotizing enterocolitis). * Concurrent participation in other interventional clinical trials. * Planned long-term use of other commercial probiotic/prebiotic supplements outside the study protocol during the intervention period. * High risk of loss to follow-up (e.g., expected relocation).

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Conditions

The condition(s) this trial relates to.

Dysbiosis neurodevelopmental disorder Premature Birth

As listed by the trial registrant

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

Dysbiosis Neurodevelopmental disorders Premature birth

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Shanghai Children's Hospital

    Shanghai, Shanghai Municipality, 200062, China

More trials for these conditions

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