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New baby formulas put to the test: will they help infants grow and feel better?

NCT ID NCT05868408

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Updated 2 times

Summary

This study looks at whether two experimental partially hydrolyzed whey-based infant formulas are as good as a standard formula for healthy full-term babies. About 234 infants will be fed one of three formulas for the first 4 months. Researchers will track weight gain and use parent questionnaires to measure digestive comfort and stool 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.

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 234 people

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

Started

Aug 2023

Expected to finish

Jun 2028

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 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: 1. Written informed consent has been obtained from at least one parent (or other legally acceptable representative \[LAR\]), if applicable) 2. Infant gestational age ≥37 completed weeks 3. Infant birth weight of ≥2.5 kg and ≤4.5 kg 4. Singleton birth 5. For Saudi: Infant postnatal age ≤28 days (date of birth = day 0); For Philippines: Infant postnatal age ≥ 14 days and ≤ 28 days (date of birth = day 0). 6. Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk 7. Infant's parent(s)/LAR is of legal age of majority, must understand the informed consent form and other relevant study documents, and is willing and able to fulfill the requirements of the study protocol Exclusion Criteria: 1. Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth 2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis) 3. Maternal medical conditions known to affect infant growth (e.g., untreated preeclampsia or gestational diabetes) 4. Infants with special dietary needs other than standard infant formula 5. Infants with known (or symptoms suggestive of) cow's milk protein intolerance/allergy, or lactose intolerance or severe food allergies that impact diet 6. Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study 7. Currently participating or having participated in another interventional clinical trial prior to enrollment

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As listed by the trial registrant

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

Growth and development Infant development Infant formula Infant health Infant nutritional physiological phenomena

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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

  • Biomedical Research Institute

    RECRUITING

    Cavite City, Philippines

  • Biomedical Research Institute

    RECRUITING

    Las Piñas, Philippines

  • King Faisal Specialist Hospital and Research Center

    COMPLETED

    Riyadh, Saudi Arabia

  • National Guard Hospital

    ACTIVE_NOT_RECRUITING

    Jeddah, Saudi Arabia

  • National Guard Hospital

    COMPLETED

    Riyadh, Saudi Arabia

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