Recruiting

Invest investigational & marketedExtensively Hydrolyzed Formula Growth Monitioring Study (GMS)

Sponsor:

Mead Johnson Nutrition

Code:

NCT07513506

Conditions

Growth

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Extensively hydrolyzed casein formula (C-eHCF), commercially available

Extensively hydrolyzed casein formula (INV-eHCF)

Study Details

Brief 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).

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.

Conditions

Growth

Study ID

NCT07513506

Start date

Apr 15, 2026

Status verified date

Oct, 2026

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

214 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Extensively hydrolyzed casein formula (C-eHCF), commercially available

experimental: Extensively hydrolyzed casein formula (INV-eHCF)

Interventions

Extensively hydrolyzed casein formula (C-eHCF), commercially available

A commercially available extensively hydrolyzed casein formula

Extensively hydrolyzed casein formula (INV-eHCF)

An extensively hydrolyzed casein formula

Primary outcome measure

Rate of weight gain (g/day) [ Time Frame: up to 131 days of age ]

Central Contacts and Locations

Central contacts

Amy Benson

812-760-9939 amy.benson@reckitt.com

Locations

Alabama Clinical Therapeutics

Recruiting

Birmingham, Alabama, United States, 35235

Contacts

Jill Andringa

205-933-8522 jill.andringa@actstudy.net

Principal Investigator:

Max Hale

Alabama Clinical Therapeutics

Recruiting

Birmingham, Alabama, United States, 35235

Contacts

Jill Andringa

205-833-2228 jill.andringa@actstudy.net

Principal Investigator:

Shameza Boyd, MD

Childrens Clinic of Jonesboro

Recruiting

Jonesboro, Arkansas, United States, 72401

Contacts

Kim Henderson

870-934-3133 kimhenderson@jbrkids.com

Principal Investigator:

Kevin Rouse, MD

SPRIM

Recruiting

Harbor Beach, Florida, United States, 32937

Contacts

Jennifer Ralph

862-881-9904 jennifer.ralph@sprim.net

Principal Investigator:

Thomas Lynch, MD

Symphony Research

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Christian Herring

954-348-4613 chering@symphonyresearch.com

Principal Investigator:

Daniel McDyer, MD

Mid Valley Research Inc.

Recruiting

Moline, Illinois, United States, 61265

Contacts

Amie Khan

(563) 528-4690 nafeeskh20@gmail.com

Principal Investigator:

Nafees Khan, MD

Springs Medical Research

Recruiting

Owensboro, Kentucky, United States, 42303

Contacts

Pam Yeiser

270-683-3232 yeiserps@gmail.com

Principal Investigator:

Michael Yeiser, MD

InnovoResearch

Recruiting

Wilmington, North Carolina, United States, 28405

Contacts

Chantal Pelzer

336-972-2909 start-up@innovoresearch.com

Principal Investigator:

Pamela Taylor, DO

AVIATI Healthcare & Clinical Research

Recruiting

Memphis, Tennessee, United States, 38115

Contacts

Ashiqua Jackson

901-482-3606 aviatihealth@gmail.com

Principal Investigator:

Katosha Muse, MD

NeutraLife Science

Recruiting

Richmond, Texas, United States, 77469

Contacts

Sydney Jim

281-598-0200 sydney.jim@neutralifesciences.com

Principal Investigator:

Michael Bornstein, MD

AMR

Recruiting

Syracuse, Utah, United States, 84075

Contacts

715-257-4351 jason.huntington@amrllc.com

Principal Investigator:

Peter Silas, MD

More Information

Sponsor

Mead Johnson Nutrition

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by Mead Johnson Nutrition on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.