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Probiotics may shield preterm infants from fatal gut infection

NCT ID NCT07233382

Prevention Sponsor: Hayatabad Medical Complex 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Updated 2 times

Summary

This study tests whether giving probiotics to preterm babies (born before 35 weeks) can prevent necrotizing enterocolitis (NEC), a severe gut infection. About 196 infants will receive either probiotics or a placebo within 24 hours of birth. The main goal is to see if fewer babies on probiotics develop NEC compared to those on placebo.

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 196 people

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

Started

Apr 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 1 day

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Male and female preterm infants with a gestational age less than 35 weeks. * All indoor patients and outdoor patients who present within 24hrs of birth Exclusion Criteria: * • Infants with congenital or developmental gastrointestinal disorders for example omphalocele, malrotation, gastroschisis. * Infants with severe sepsis or gastrointestinal bleeding on presentation

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Conditions

The condition(s) this trial relates to.

neuroendocrine carcinoma necrotizing enterocolitis prevention target

As listed by the trial registrant

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

NEC Nec - necrotizing enterocolitis

Contacts and locations

Locations

  • Hayatabad Medical Complex

    Peshawar, KPK, 25000, Pakistan

More trials for these conditions

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