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Breast milk enemas: a new hope for preterm infant gut health?

NCT ID NCT07558499

Knowledge-focused Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 breast milk enemas to preterm babies can improve their gut bacteria and reduce complications like feeding problems. Sixty preterm infants will receive either breast milk or saltwater enemas for five days. The goal is to see if this simple approach helps their gut develop better.

What this could mean

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

Active substance
maternal breast milk
What this could lead to
If it works, this could point toward a simple, non-invasive way to support gut health in preterm infants.
What could go wrong
This is a very small, early study with only 60 infants. It may not show clear benefits, and the approach is experimental with unknown risks.

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 60 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

Aug 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

22 to 32 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 ≤32 weeks and birth weight ≤1500 g Infants without meconium passage within the first 48 hours of life Infants whose parents have provided written informed consent Exclusion Criteria: nfants with major congenital anomalies Infants with gastrointestinal system anomalies Infants in whom administration of maternal breast milk is contraindicated Infants whose parents do not provide consent for participation Infants who die within the first 72 hours of life

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Conditions

The condition(s) this trial relates to.

necrotizing enterocolitis Premature Birth

As listed by the trial registrant

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

Gut microbiota diversity and composition Nec - necrotizing enterocolitis Premature

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

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