Extensively Hydrolyzed Formula Growth Monitioring Study (GMS)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Mead Johnson Nutrition
Study ID
NCT07513506
Status
Not Yet Recruiting

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Conditions

  • Growth

Eligibility Criteria

Sex
ALL
Age
10 Days - 14 Days
Healthy Volunteers
Accepted

Interventions

  • Extensively hydrolyzed casein formula (C-eHCF), commercially available — OTHER
    A commercially available extensively hydrolyzed casein formula
  • Extensively hydrolyzed casein formula (INV-eHCF) — OTHER
    An extensively hydrolyzed casein formula

Study Details

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.

Key Dates

Start date
Apr 3, 2026
Status verified
Mar 2026
Primary completion
Dec 1, 2026
Completion
May 1, 2027

Study Design

Enrollment
214 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Extensively hydrolyzed casein formula (C-eHCF), commercially available
  • Experimental: Extensively hydrolyzed casein formula (INV-eHCF)

Primary Outcome Measure

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

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Alabama Clinical TherapeuticsBirminghamAlabama35235
Jill Andringa
[email protected]
205-933-8522
Max Hale (PRINCIPAL_INVESTIGATOR)
Alabama Clinical TherapeuticsBirminghamAlabama35235
Jill Andringa
[email protected]
205-833-2228
Shameza Boyd, MD (PRINCIPAL_INVESTIGATOR)
Childrens Clinic of JonesboroJonesboroArkansas72401
Kim Henderson
[email protected]
870-934-3133
Kevin Rouse, MD (PRINCIPAL_INVESTIGATOR)
SPRIMHarbor BeachFlorida32937
Jennifer Ralph
[email protected]
862-881-9904
Thomas Lynch, MD (PRINCIPAL_INVESTIGATOR)
Symphony ResearchJacksonvilleFlorida32224
Christian Herring
[email protected]
954-348-4613
Daniel McDyer, MD (PRINCIPAL_INVESTIGATOR)
Hope Research NetworkVirginia GardensFlorida33166
Patricia Jorge
[email protected]
786-627-4673
Mario Reyes, MD (PRINCIPAL_INVESTIGATOR)
Mid Valley Research Inc.MolineIllinois61265-
Springs Medical ResearchOwensboroKentucky42303-
InnovoResearchWilmingtonNorth Carolina28405
Chantal Pelzer
[email protected]
336-972-2909
Pamela Taylor, DO (PRINCIPAL_INVESTIGATOR)
AVIATI Healthcare & Clinical ResearchMemphisTennessee38115-
NeutraLife ScienceRichmondTexas77469
Sydney Jim
[email protected]
281-598-0200
Michael Bornstein, MD (PRINCIPAL_INVESTIGATOR)
AMRSyracuseUtah84075
[email protected]
715-257-4351
Peter Silas, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
Alabama Clinical Therapeutics· Birmingham, ALChildrens Clinic of Jonesboro· Jonesboro, ARSPRIM· Harbor Beach, FLSymphony Research· Jacksonville, FLHope Research Network· Virginia Gardens, FLMid Valley Research Inc.· Moline, IL

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