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New baby formula with breast milk sugars studied for safety and growth

NCT ID NCT07302477

Knowledge-focused Sponsor: Société des Produits Nestlé (SPN) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new infant formula containing human milk oligosaccharides (HMOs), which are natural sugars found in breast milk, in 125 healthy full-term babies. The goal was to see if the formula supports normal growth and is easy for babies to digest in everyday, real-world conditions. Researchers measured weight, length, head size, and digestive comfort over 8 weeks. The study did not compare the formula to any other feeding method, so it provides early information on how well babies tolerate HMO-supplemented formula outside of a controlled lab setting.

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 supplemented with human milk oligosaccharides (HMOs) and Bifidobacterium lactis
What this could lead to
If successful, this could show that HMO-supplemented formula is a safe and well-tolerated option for healthy infants, potentially supporting normal growth and digestive health.
What could go wrong
This is a small, uncontrolled study without a comparison group, so results may not be conclusive. It only looks at short-term outcomes over 8 weeks, and any benefits seen might not hold up in larger, more rigorous trials.

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

125 people

The number who actually took part.

Started

Jul 2021

Finished

Dec 2022

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

7 days to 2 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: 1. Evidence of personally signed and dated informed consent document indicating that the infant's parent(s) has been informed of all pertinent aspects of the study 2. Parent(s) Are willing and able to fulfill the requirements of the study protocol 3. Healthy full term (37-42 weeks gestation) infant 4. Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months 5. Parent(s) must have independently elected, before enrollment, to formula feed. IF or mixed feeding. Prior to enrollment parents were counselled about the superiority and advantages of exclusive breastfeeding. Exclusion Criteria: 1. Had any known case of intolerance/allergy to cow's milk (for formula-fed group only) 2. Had conditions requiring infant feedings other than those specified in the protocol 3. Evidence of significant cardiac, respiratory, endocrinologist, hematologic, gastrointestinal, or other systemic diseases/disorders 4. Parent(s) refusal to participate in the study 5. Infant had consumed any other infant formula in 3 days prior to study start

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As listed by the trial registrant

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

Adverse event GROWTH Tolerance

Contacts and locations

Locations

  • Fatima Memorial Hospital

    Lahore, Pakistan

  • Khawaja Muhammad Safdar Medical College

    Sialkot, Pakistan

  • Liaqat National Hospital

    Karachi, Pakistan

  • Quaid E Azam Medical College

    Chak Four Hundred Fifty-four, Pakistan

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