NCT07513506 · Mead Johnson Nutrition
Extensively Hydrolyzed Formula Growth Monitioring Study (GMS)
What this study is about
This is a research study to compare an experimental infant formula against a currently marketed infant formula. An experimental infant formula is one that has never been approved by the United States Food and Drug Administration (FDA).
View original scientific description
This is a research study to compare an investigational infant formula against a currently marketed infant formula. An investigational infant formula is one that has never been approved by the United States Food and Drug Administration (FDA). The purpose of this research study is to evaluate the growth and tolerance of infants who consume a new (not yet available to buy) extensively hydrolyzed cow milk protein infant formula compared to an extensively hydrolyzed cow milk protein infant formula that is currently available to buy. The study will also look at the growth of your baby, how many poops your baby has, what the poops are like (for example, soft or hard), how much study formula your baby drinks, how well your baby handles the study formula (such as spit-up, fussiness, gas, colic, or changes in sleep), and any health problems that might come up during the study.
Interventions
OTHER
Extensively hydrolyzed casein formula (C-eHCF), commercially available
A commercially available extensively hydrolyzed casein formula
OTHER
Extensively hydrolyzed casein formula (INV-eHCF)
An extensively hydrolyzed casein formula
Primary outcome measures
Rate of weight gain (g/day)
Time frame: up to 131 days of age
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Birmingham, Alabama
- Jonesboro, Arkansas
- Harbor Beach, Florida
- Jacksonville, Florida
- Virginia Gardens, Florida
- Moline, Illinois
- Owensboro, Kentucky
- Wilmington, North Carolina
- Memphis, Tennessee
- Richmond, Texas
- Syracuse, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 20, 2026 · Source of record for eligibility and locations