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Probiotics show promise for preterm infants: could reduce deadly gut infections

NCT ID NCT07296718

Disease control Sponsor: Madiha, MPhil 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether giving probiotics (single or multiple strains) to 249 premature babies for 28 days after birth could prevent necrotizing enterocolitis, sepsis, and improve growth. The babies were born before 36 weeks and weighed under 2500 grams. Researchers compared a single-strain probiotic, a multi-strain mix, and a placebo to see which worked best.

What this could mean

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

Active substance
Probiotics (Lactobacillus Rhamnosus GG or a mix of Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4)
What this could lead to
If probiotics work, they could offer a simple, low-cost way to reduce dangerous gut infections and improve growth in premature babies.
What could go wrong
This is a completed Phase 4 trial, but results may not apply to all preterm infants. Probiotics can rarely cause infections in very fragile babies.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

249 people

The number who actually took part.

Started

May 2023

Finished

Oct 2025

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

Up to 36 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 babies of gestational age \<35+6days, birth weight \<2500 grams, received and tolerated at-least one feed within 72 hours of birth and informed consent from parents or guardian. Exclusion Criteria: * Neonates with major congenital malformations, gastrointestinal anomalies, early onset sepsis (C-reactive protein (CRP) \>10 mg/L in the first 72 h of life) and renal insufficiency

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Conditions

The condition(s) this trial relates to.

necrotizing enterocolitis neonatal sepsis perinatal necrotizing enterocolitis prevention target

As listed by the trial registrant

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

Feeding intolerance GROWTH Necrotizing enterocolitis of newborn Sepsis newborn

Contacts and locations

Locations

  • Bahawal Victoria Hospital

    Bahawalpur, Punjab Province, 62100, Pakistan

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