Extensively Hydrolyzed Formula Growth Monitioring Study (GMS)

March 30, 2026 updated by: Mead Johnson Nutrition

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Alabama Clinical Therapeutics
        • Principal Investigator:
          • Shameza Boyd, MD
        • Contact:
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Childrens Clinic of Jonesboro
        • Principal Investigator:
          • Kevin Rouse, MD
        • Contact:
    • Florida
      • Harbor Beach, Florida, United States, 32937
        • SPRIM
        • Contact:
        • Principal Investigator:
          • Thomas Lynch, MD
      • Jacksonville, Florida, United States, 32224
        • Symphony Research
        • Principal Investigator:
          • Daniel McDyer, MD
        • Contact:
      • Virginia Gardens, Florida, United States, 33166
        • Hope Research Network
        • Principal Investigator:
          • Mario Reyes, MD
        • Contact:
    • Illinois
      • Moline, Illinois, United States, 61265
        • Mid Valley Research Inc.
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Springs Medical Research
    • North Carolina
      • Wilmington, North Carolina, United States, 28405
        • InnovoResearch
        • Contact:
        • Principal Investigator:
          • Pamela Taylor, DO
    • Tennessee
      • Memphis, Tennessee, United States, 38115
        • AVIATI Healthcare & Clinical Research
    • Texas
      • Richmond, Texas, United States, 77469
    • Utah
      • Syracuse, Utah, United States, 84075

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Extensively hydrolyzed casein formula (C-eHCF), commercially available
Other: Extensively hydrolyzed casein formula (C-eHCF), commercially available
A commercially available extensively hydrolyzed casein formula
Experimental: Extensively hydrolyzed casein formula (INV-eHCF)
Other: Extensively hydrolyzed casein formula (INV-eHCF)
An extensively hydrolyzed casein formula

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body length (cm)
Time Frame: up to 131 days of age
up to 131 days of age
Head Circumference (cm)
Time Frame: up to 131 days of age
up to 131 days of age
Body weight (g)
Time Frame: up to 131 days of age
up to 131 days of age
Growth z-scores
Time Frame: up to 131 days of age
head circumference-for-age
up to 131 days of age
Growth Z Scores
Time Frame: up to 131 days of age
weight-for-age
up to 131 days of age
Growth Z Scores
Time Frame: up to 131 days of age
Length-for-age
up to 131 days of age
Stool characteristics
Time Frame: up to 131 days of age
up to 131 days of age
Study formula intake
Time Frame: up to 131 days of age
up to 131 days of age
Tolerance
Time Frame: up to 131 days of age
up to 131 days of age
Medically confirmed adverse events
Time Frame: up to 131 days of age
up to 131 days of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mead Johnson Nutrition

Investigators

  • Study Director: Veronica Fabrizio, DO, Mead Johnson Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 3, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 3397-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Growth

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe