GrowthNCT07513506
Extensively Hydrolyzed Formula Growth Monitioring Study (GMS)
A study testing Extensively hydrolyzed casein formula (C-eHCF), commercially available and Extensively hydrolyzed casein formula (INV-eHCF) in people with Growth, run by Mead Johnson Nutrition at 12 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 10 to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Growth
- What is being tested?
- Extensively hydrolyzed casein formula (C-eHCF), commercially available and Extensively hydrolyzed casein formula (INV-eHCF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 12 sitesUnited States
- Study dates
- 15 Apr 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
Jill Andringa, 205-933-8522, jill.andringa@actstudy.net
Max Hale
- Recruiting
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
Jill Andringa, 205-833-2228, jill.andringa@actstudy.net
Shameza Boyd, MD
- Recruiting
SPRIM
Harbor Beach, Florida, 32937
Jennifer Ralph, 862-881-9904, jennifer.ralph@sprim.net
Thomas Lynch, MD
- Recruiting
Symphony Research
Jacksonville, Florida, 32224
Christian Herring, 954-348-4613, chering@symphonyresearch.com
Daniel McDyer, MD
- Recruiting
Childrens Clinic of Jonesboro
Jonesboro, Arkansas, 72401
Kim Henderson, 870-934-3133, kimhenderson@jbrkids.com
Kevin Rouse, MD
- Recruiting
AVIATI Healthcare & Clinical Research
Memphis, Tennessee, 38115
Ashiqua Jackson, 901-482-3606, aviatihealth@gmail.com
Katosha Muse, MD
- Recruiting
Mid Valley Research Inc.
Moline, Illinois, 61265
Amie Khan, (563) 528-4690, nafeeskh20@gmail.com
Nafees Khan, MD
- Recruiting
Springs Medical Research
Owensboro, Kentucky, 42303
Pam Yeiser, 270-683-3232, yeiserps@gmail.com
Michael Yeiser, MD
- Recruiting
NeutraLife Science
Richmond, Texas, 77469
Sydney Jim, 281-598-0200, sydney.jim@neutralifesciences.com
Michael Bornstein, MD
- Recruiting
AMR
Syracuse, Utah, 84075
715-257-4351, jason.huntington@amrllc.com
Peter Silas, MD
- Not yet recruiting
Hope Research Network
Virginia Gardens, Florida, 33166
Patricia Jorge, 786-627-4673, pjorge@hoperesearch.net
Mario Reyes, MD
- Recruiting
InnovoResearch
Wilmington, North Carolina, 28405
Chantal Pelzer, 336-972-2909, start-up@innovoresearch.com
Pamela Taylor, DO
About this study
Official title: GROWTH AND TOLERANCE OF A NEW INFANT FORMULA USING AN EXTENSIVELY HYDROLYZED CASEIN-BASED PROTEIN (eHCF)
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.
Read the detailed description
The current study is designed to demonstrate that an investigational extensively hydrolyzed casein formula developed utilizing a new manufacturing process, is well-accepted, tolerated and supports typical growth similar to a control extensively hydrolyzed casein formula in term, healthy infants from approximately 14 to 126 days of age. This formula has been determined to have a high-quality protein similar to that of intact casein, as seen in the protein efficiency ratio (PER) study. Secondary objectives will include tolerance, intake and stool characteristics between infants assigned to receive the control or the investigational formula through approximately 126 days of age. Control and investigational formulas have the same nutritional composition per 100 kcal.
- Conditions
- Growth
- Being tested
- Extensively hydrolyzed casein formula (C-eHCF), commercially available, Extensively hydrolyzed casein formula (INV-eHCF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extensively hydrolyzed casein formula (C-eHCF), commercially availableOther
A commercially available extensively hydrolyzed casein formula
Extensively hydrolyzed casein formula (INV-eHCF)Other
An extensively hydrolyzed casein formula
| Study group | Role | What they receive |
|---|---|---|
| Extensively hydrolyzed casein formula (C-eHCF), commercially available | Active comparator | Not described Receives: Other: Extensively hydrolyzed casein formula (C-eHCF), commercially available |
| Extensively hydrolyzed casein formula (INV-eHCF) | Experimental | Not described Receives: Other: Extensively hydrolyzed casein formula (INV-eHCF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of weight gain (g/day)
Measured: up to 131 days of age
Secondary outcomes (10)
body length (cm)
Measured: up to 131 days of age
Head Circumference (cm)
Measured: up to 131 days of age
Body weight (g)
Measured: up to 131 days of age
Growth z-scores
head circumference-for-age
Measured: up to 131 days of age
Growth Z Scores
weight-for-age
Measured: up to 131 days of age
Growth Z Scores
Length-for-age
Measured: up to 131 days of age
Stool characteristics
Measured: up to 131 days of age
Study formula intake
Measured: up to 131 days of age
Tolerance
Measured: up to 131 days of age
Medically confirmed adverse events
Measured: up to 131 days of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start15 Apr 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GrowthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Veronica Fabrizio, DO, Study director, Mead Johnson Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513506
- Sponsor's protocol ID
- 3397-2
- Status last verified
- Oct 2026
- First submitted
- 23 Mar 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GROWTH AND TOLERANCE OF A NEW INFANT FORMULA USING AN EXTENSIVELY HYDROLYZED CASEIN-BASED PROTEIN (eHCF)
- ClinicalTrials.gov ID
- NCT07513506
- Acronym / sponsor ID
- 3397-2
- Conditions
- Growth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The current study is designed to demonstrate that an investigational extensively hydrolyzed casein formula developed utilizing a new manufacturing process, is well-accepted, tolerated and supports typical growth similar to a control extensively hydrolyzed casein formula in term, healthy infants from approximately 14 to 126 days of age. This formula has been determined to have a high-quality protein similar to that of intact casein, as seen in the protein efficiency ratio (PER) study. Secondary objectives will include tolerance, intake and stool characteristics between infants assigned to receive the control or the investigational formula through approximately 126 days of age. Control and investigational formulas have the same nutritional composition per 100 kcal.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extensively hydrolyzed casein formula (C-eHCF), commercially available | Active comparator | Other: Extensively hydrolyzed casein formula (C-eHCF), commercially available |
| Extensively hydrolyzed casein formula (INV-eHCF) | Experimental | Other: Extensively hydrolyzed casein formula (INV-eHCF) |
Who may qualify
- Ages
- 10 to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (6 listed)
- 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%]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extensively hydrolyzed casein formula (C-eHCF), commercially availableA commercially available extensively hydrolyzed casein formula | Other | Extensively hydrolyzed casein formula (C-eHCF), commercially available |
| Extensively hydrolyzed casein formula (INV-eHCF)An extensively hydrolyzed casein formula | Other | Extensively hydrolyzed casein formula (INV-eHCF) |
Primary outcome
Rate of weight gain (g/day)
Time frame: up to 131 days of age
10 secondary outcomes
body length (cm)
Time frame: up to 131 days of age
Head Circumference (cm)
Time frame: up to 131 days of age
Body weight (g)
Time frame: up to 131 days of age
Growth z-scores
Time frame: up to 131 days of age
Growth Z Scores
Time frame: up to 131 days of age
Growth Z Scores
Time frame: up to 131 days of age
Stool characteristics
Time frame: up to 131 days of age
Study formula intake
Time frame: up to 131 days of age
Tolerance
Time frame: up to 131 days of age
Medically confirmed adverse events
Time frame: up to 131 days of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Veronica Fabrizio, DO study director
Mead Johnson Nutrition
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extensively hydrolyzed casein formula (C-eHCF), commercially available and Extensively hydrolyzed casein formula (INV-eHCF) in people with Growth, run by Mead Johnson Nutrition at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Benson (812-760-9939, amy.benson@reckitt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of weight gain (g/day) (time frame: up to 131 days of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.