New baby formula study aims for better growth and digestion
NCT ID NCT07513506
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
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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
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About 214 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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10 to 14 days
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
12 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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AMR
Syracuse, Utah, 84075, United States
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AVIATI Healthcare & Clinical Research
Memphis, Tennessee, 38115, United States
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Alabama Clinical Therapeutics
Birmingham, Alabama, 35235, United States
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Alabama Clinical Therapeutics
Birmingham, Alabama, 35235, United States
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Childrens Clinic of Jonesboro
Jonesboro, Arkansas, 72401, United States
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Hope Research Network
Virginia Gardens, Florida, 33166, United States
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InnovoResearch
Wilmington, North Carolina, 28405, United States
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Mid Valley Research Inc.
Moline, Illinois, 61265, United States
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NeutraLife Science
Richmond, Texas, 77469, United States
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SPRIM
Harbor Beach, Florida, 32937, United States
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Springs Medical Research
Owensboro, Kentucky, 42303, United States
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Symphony Research
Jacksonville, Florida, 32224, United States
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