Cure My Disease

Don't miss your cure!

 Log in / Sign up

Milk particles may shield preemies from deadly gut condition

NCT ID NCT07402083

Prevention Sponsor: Instituto de Investigacion Sanitaria La Fe Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tiny particles called extracellular vesicles, naturally found in human milk, can prevent necrotizing enterocolitis (NEC) in very premature infants. Twenty babies born before 32 weeks will receive these particles as a supplement. Researchers will monitor safety, feeding tolerance, and growth to see if this approach can reduce the risk of this dangerous gut condition.

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.

Participants

About 20 people

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

Started

Feb 2026

Expected to finish

Dec 2029

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.

Who is studied

Preterm infants at risk of developing necrotizing enterocolitis (NEC), recruited between 14 and 28 days of life during their stay in the Neonatal Intensive Care Unit (NICU). A total of 20 infants will be enrolled to receive oral administration of extracellular vesicles (EVs) isolated from donor human milk (DHM) as a dietary supplement.

Ages

0 to 14 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: * Preterm infants born at \<32 weeks gestational age * Age between 0 and 14 days of life at enrollment * At risk of developing necrotizing enterocolitis (NEC) * Written informed consent obtained from parent(s) or legal guardian(s) Exclusion Criteria: * Major congenital anomalies or chromosomal abnormalities * Severe gastrointestinal malformations (e.g., gastroschisis, intestinal atresia) * Conditions incompatible with enteral feeding or EV supplementation * Participation in another interventional clinical trial

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Very preterm infants (<32 weeks of gestation) are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Premature Birth necrotizing enterocolitis prevention target

As listed by the trial registrant

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

Very preterm infants (<32 weeks of gestation)

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Hospital Universitario y Politécnico La Fe

    RECRUITING

    Valencia, Valencia, 46026, Spain