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Probiotic drops may shield preemies from fatal gut infection

NCT ID NCT05710575

Disease control Sponsor: University of Health Sciences Lahore 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether giving a probiotic (Lactobacillus reuteri) to premature infants could reduce the risk of necrotizing enterocolitis (NEC), a severe gut infection, and death. One hundred babies born between 28 and 36 weeks and weighing 1000-2500 grams were enrolled. The probiotic group received daily drops, while the control group got no treatment. Researchers tracked NEC, sepsis, feeding tolerance, and hospital stay length.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Probiotic (Lactobacillus reuteri)
What this could lead to
If probiotics reduce NEC and death in preemies, this could become a standard, low-cost addition to NICU care for vulnerable infants.
What could go wrong
This is a small, single-center study (100 infants). Results may not apply to all preemies, and probiotics could rarely cause infections 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

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

100 people

The number who actually took part.

Started

Feb 2023

Finished

Sep 2023

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

28 to 36 weeks

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: * Premature infants with gestational age of more than 28 weeks and less than 36 weeks * Birth weight of 1000 - 2500 grams * Admitted to the neonatal intensive care unit (NICU) of Pediatric Medicine Unit II, Services hospital Lahore * With intestinal feeding. Exclusion Criteria: * Infants with major congenital malformations (including congenital heart disease, gastrointestinal obstruction, gastroschisis, etc.) * Congenital metabolic errors hypoxic ischemic encephalopathy (HIE) of grade two or more according to Sarnat scoring system (Gordon et al., 2020) * Death in the first 72 hours of life * Newborns of addicted mothers * Postpartum age more than two weeks * Parental unacceptance

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Conditions

The condition(s) this trial relates to.

necrotizing enterocolitis Premature Birth perinatal necrotizing enterocolitis prevention target

As listed by the trial registrant

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

Necrotizing enterocolitis of newborn

Contacts and locations

Locations

  • services hospital Pakistan

    Lahore, Punjab Province, 54610, Pakistan

More trials for these conditions

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