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New baby formula aims to boost good gut bacteria in infants

NCT ID NCT07242508

Disease control Sponsor: FrieslandCampina 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 2 times

Summary

This study tests if a new infant formula can increase healthy gut bacteria (Bifidobacterium) in healthy, full-term babies. Researchers will compare the new formula to a standard one over 10 weeks. The study involves 120 infants whose parents have chosen not to breastfeed.

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 120 people

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

Started

Nov 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

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 3 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: * Healthy, full term, infants with a birth weight between 2500-4500 grams * Parents independently from study decided to not breastfeed their infant * Parents agree to feed the assigned study formula as the infant's sole source of nutrition for the duration of the study * have read and voluntarily signed an informed consent form * parents are capable of completing study procedures required by the protocol Exclusion Criteria: * suffering from any anatomic and/or physiologic condition that would interfere with normal growth, development or feeding * are required to take medications or supplements known to influence growth and development * have a maternal history with known adverse effects on the fetus and/or the newborn infant * have previous or current antibiotics use (antibiotics administered during delivery are permitted) * have received or are planning to receive probiotics, prebiotics, or nutritional supplements prior to and throughout the trial (excluding vitamin D and vitamin K supplementation) * personal history of or parents/siblings diagnosed with cow's milk protein allergy or lactose intolerance * multiple birth * participation in another trial

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As listed by the trial registrant

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

Healthy infants

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

  • Second SAGBAL Sheinovo AD

    RECRUITING

    Sofia, Bulgaria

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