Could a formula closer to breast milk boost baby development?

NCT ID NCT06569797

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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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study compares a new infant formula that includes human milk oligosaccharides (special sugars found in breast milk) and a blend of optimized nutrients against standard formula and breastfeeding. About 240 healthy newborns will be followed for their first year, with measurements of growth, mental and motor development, and gut health. The goal is to see if this enhanced formula can better support infant development.

What this could mean

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

Active substance
a new infant formula with added human milk oligosaccharides and optimized nutrients
What this could lead to
If successful, this formula could help bridge the nutritional gap between standard formula and breast milk, potentially supporting better growth and gut health in formula-fed infants.
What could go wrong
This is an early-stage study with only 240 babies, so results may not apply to all infants. The new formula may not show clear benefits over standard formula or breastfeeding.

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

240 people

The number who actually took part.

Started

Jan 2024

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 28 days

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: Breastfed Group Infants eligible for the breastfed reference group must meet all of the following criteria: * Aged 0 to 28 days after birth (inclusive). * Singleton birth. * Gestational age between 37 and 42 weeks (inclusive). * Birth weight between 2500 and 4000 grams (inclusive). * Parent(s) or legal guardian(s) agree that the infant will not participate in any other interventional clinical studies for the duration of this trial. * Parent(s) or legal guardian(s) agree to feed the infant according to the trial protocol (i.e., breastfeeding). Formula-fed Group Infants eligible for the randomized formula-fed groups must meet all of the following criteria: * Aged 0 to 28 days after birth (inclusive). * Singleton birth. * Gestational age between 37 and 42 weeks (inclusive). * Birth weight between 2500 and 4000 grams (inclusive). * Parent(s) or legal guardian(s) agree that the infant will not participate in any other interventional clinical studies for the duration of this trial. * Parent(s) or legal guardian(s) agree to feed the infant according to the trial protocol. * For objective or subjective reasons, the mother is unable to provide exclusive breastfeeding. Exclusion Criteria: Infants will be excluded from the trial if they meet any of the following criteria: * Conceived through assisted reproductive technology. * Maternal history of any condition during pregnancy known to compromise intrauterine growth. * Maternal history of gestational diabetes, significant metabolic disease, or chronic disease during pregnancy. * Presence of congenital malformations, genetic disorders, chronic diseases, or congenital conditions that could interfere with the study participation or outcome assessments. * Known IgE-mediated cow's milk protein allergy, or presence of factors that increase the risk of cow's milk protein allergy. * Active acute infection or gastroenteritis at the time of enrollment. * History of functional gastrointestinal disorders, such as gastroparesis. * Concurrent participation in another clinical trial. * Any condition that, in the investigator's judgment, could compromise the parent's willingness or ability to comply with the protocol requirements.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Changzhou Second People's Hospital

    Changzhou, Jiangsu, 213000, China

  • Linyi City Maternal and Child Health Care Hospital

    Linyi, Shandong, 276016, China

  • Nanjing Medical University

    Nanjin, Jiangsu, 211100, China

  • Seventh Medical Center, Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100010, China

  • The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin, Tianjin Municipality, 300381, China

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210003, China

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