Cure My Disease

Don't miss your cure!

 Log in / Sign up

What shapes breast milk? a deep dive into its composition

NCT ID NCT06152835

Knowledge-focused Sponsor: Federico II University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This study looks at breast milk in detail, analyzing its nutrients, microbes, and other components at different times of the day and during feedings. Researchers will collect milk samples from 100 Italian women who exclusively breastfeed their healthy, full-term babies. They will also gather information about the mothers' diet, lifestyle, and health to see how these factors might influence milk composition. The goal is to better understand what makes breast milk beneficial and how to support mothers who cannot breastfeed.

What this could mean

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

Active substance
Data and breast milk sample collection
What this could lead to
If successful, this study could help define optimal nutrient ranges for breastfed infants and guide dietary advice for mothers to improve milk quality.
What could go wrong
This is an observational study, so it cannot prove cause and effect. Results may not apply to non-Italian women or those with different feeding patterns.

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

100 people

The number who actually took part.

Started

Jul 2023

Finished

Jul 2026

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

100 Italian women, aged 20-40 years, who breastfed children born at full term, observed at the specialist pediatric clinics of the "Federico II" University Hospital of Naples, of the "La Sapienza University of Rome", of the "La Statale University of Milan", the "University of Pisa" and the "University of Verona".

Ages

20 to 40 years

Sex

Female participants only

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: * Italian women aged between 20 and 40 years who exclusively breastfeed children born at term from normal pregnancy * Written informed consent Exclusion Criteria: * Non-Italian women; * Age \<20 and \>40 years; * Mothers of children born preterm; * Non-exclusive breastfeeding; * Mothers suffering from chronic diseases: * malignancies; * immunodeficiencies; * chronic infections; * autoimmune diseases; * chronic inflammatory intestinal diseases; * celiac disease; * genetic-metabolic diseases; * cystic fibrosis; * chronic lung diseases; * malformations of the cardiovascular/respiratory/gastrointestinal system; * neuropsychiatric disorders; * neurological diseases.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breastfeeding are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Breast Feeding

As listed by the trial registrant

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

Breastfeeding

Contacts and locations

Locations

  • Department of Traslational Medical Science - University of Naples Federico II

    Naples, Naples, 80131, Italy

More trials for these conditions

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