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Baby formula gets a breast milk boost: study checks gut bugs

NCT ID NCT06059209

Knowledge-focused Sponsor: University of Arizona 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how different infant diets affect gut bacteria in healthy, full-term babies. Researchers are comparing a standard formula, a new formula designed to be more like breast milk (Enfamil NeuroPro), and breast milk itself. They will track changes in gut bacteria, genes, and chemicals from stool samples over time. The goal is to see if the new formula helps create a gut environment closer to that of breastfed babies.

What this could mean

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

Active substance
Infant formula with milk fat globule membrane and 2'-fucosyllactose (Enfamil NeuroPro)
What this could lead to
If successful, this study could show that adding these breast-milk-like ingredients to formula supports a gut bacteria pattern closer to that of breastfed infants.
What could go wrong
This is an observational comparison of already-available formulas, not a test of a new treatment. Results may not lead to any health recommendations or changes in practice.

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 240 people

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

Started

Jan 2023

Expected to finish

May 2026

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

0 to 4 months

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: * Healthy term infants with parental consent * Parents are able to provide informed consent; own a smart phone and are able to fill out weekly digital questionnaires. Exclusion Criteria: * Prematurity (\<= 36 weeks gestational age) * Babies born through c-section * Any health issues identified at the first postpartum screening * Use of both breast milk and formula * Use of donor breast milk * Parent unwillingness/inability to avoid giving prebiotics, probiotics, symbiotics, and immune-stimulating products to the child for the duration of this study

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia childhood acute lymphoblastic leukemia

As listed by the trial registrant

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

Infant ALL Infant development

Contacts and locations

Locations

  • University of Arizona

    Tucson, Arizona, 85724, United States

More trials for these conditions

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