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Gut check: probiotic trial aims to shield preterm infants from deadly infections

NCT ID NCT07213414

Disease control Sponsor: Hasanuddin 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 special mix of three Bifidobacterium probiotics to premature babies in the NICU can improve their gut bacteria balance and reduce harmful germs. Researchers will compare two groups of 72 preterm infants—one receiving the probiotic and one not—by analyzing stool samples over three weeks. The goal is to see if probiotics can lower the risk of serious infections like necrotizing enterocolitis and sepsis, common in fragile newborns.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 72 people

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

Started

Sep 2024

Expected to finish

Sep 2025

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

0 to 3 days

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: * Premature infants (gestational age 28 to \<34 weeks) treated in the NICU with a birth weight of 1000 to \<2500 grams * No contraindications to giving the drink in the first 3 days of life * Parents agree to participate in the study and sign a consent letter. Exclusion Criteria: * Major congenital disorders * Severe sepsis * No stool production in the first 3 days of life * Received formula milk that contains probiotics

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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.

Low birth weight neonates Prematurity

Contacts and locations

Locations

  • Cahaya Medika General Hospital

    Makassar, South Sulawesi, 90245, Indonesia

  • Dr. Wahidin Sudirohusodo General Hospital

    Makassar, South Sulawesi, 90174, Indonesia

  • Hasanuddin University General Hospital

    Makassar, South Sulawesi, 90152, Indonesia

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