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New baby formula study aims for better growth and digestion

NCT ID NCT07513506

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study compares a new extensively hydrolyzed casein formula (not yet FDA-approved) to a currently available one in 214 healthy infants aged 10-14 days. Researchers will measure weight gain, length, head size, stool patterns, and tolerance (spit-up, fussiness, gas). The goal is to see if the new formula supports normal growth and is well-tolerated.

What this could mean

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

Active substance
extensively hydrolyzed casein-based infant formula
What this could lead to
If successful, this could provide a new option for infants who need a hypoallergenic formula, supporting normal growth and digestion.
What could go wrong
This is an early-stage study comparing two formulas, not a treatment for a disease. Results may not show significant differences, and individual infant tolerance can vary.

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 214 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

May 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

10 to 14 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: * 10 to 14 days of age at randomization, inclusive (day of birth is considered Day 0) * Singleton birth * Gestational age of 37 weeks + 0 days to 41 weeks + 6 days, inclusive * Birth weight of 2500 g to 4200 g, inclusive * Birth weight appropriate for gestational age (AGA, defined as birth weight-for-age between 10th and 90th percentile, inclusive) * Exclusively receiving infant formula for at least 24 hours prior to randomization * Parent(s) or legal guardian(s) have full intention to exclusively feed their infant study formula through 126 days of age * Signed informed consent obtained from parent or legal guardian for infant's participation in the study * Signed authorization obtained from parent or legal guardian to use and/or disclose Protected Health Information for the infant from birth through the length of the study period * Parent or legal guardian agrees not to enroll the infant in another interventional clinical study while participating in this study * Decentralized participant's parent/caregiver or legal guardian has access to reliable internet and technology for remote visits. * Decentralized participant's parent/caregiver or legal guardian anticipates having a second adult available for all remote visits. Exclusion Criteria: * History of underlying metabolic or chronic disease; congenital malformation; immunodeficiency, gastrointestinal condition, or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food by mouth, the normal growth and development of the infant, or the evaluation of the infant * Evidence of feeding difficulties or history of formula intolerance, such as vomiting or poor intake at time of randomization * First degree relative (if known) history of cow's milk protein intolerance or allergy * Maternal history with known adverse effects on the fetus and/or newborn infant in the opinion of the investigator, such as, but not limited to diabetes, smoking, active tuberculosis, perinatal infection, or substance abuse * Weight at Visit 1 is \<98% of birth weight \[weight at Visit 1÷ birth weight) x 100\< 98%\] * Infants whose parent, legal guardian, or first-degree relative is an employee of MJN/Reckitt or an affiliated vendor (e.g., CRO, laboratory, or data management provider) involved in the clinical trial, and who is directly or indirectly engaged in the design, conduct, oversight, or analysis of the study; has access to confidential study information; or holds supervisory authority over personnel involved in the study.

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As listed by the trial registrant

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

How to take part

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

  1. The places running it

    12 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

  • AMR

    Syracuse, Utah, 84075, United States

  • AVIATI Healthcare & Clinical Research

    Memphis, Tennessee, 38115, United States

  • Alabama Clinical Therapeutics

    Birmingham, Alabama, 35235, United States

  • Alabama Clinical Therapeutics

    Birmingham, Alabama, 35235, United States

  • Childrens Clinic of Jonesboro

    Jonesboro, Arkansas, 72401, United States

  • Hope Research Network

    Virginia Gardens, Florida, 33166, United States

  • InnovoResearch

    Wilmington, North Carolina, 28405, United States

  • Mid Valley Research Inc.

    Moline, Illinois, 61265, United States

  • NeutraLife Science

    Richmond, Texas, 77469, United States

  • SPRIM

    Harbor Beach, Florida, 32937, United States

  • Springs Medical Research

    Owensboro, Kentucky, 42303, United States

  • Symphony Research

    Jacksonville, Florida, 32224, United States

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