Clinical Trial

Extensively Hydrolyzed Formula Growth Monitioring Study (GMS)

Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07513506
Lead Sponsor Mead Johnson Nutrition
Conditions Growth
Enrollment 214 participants
Start Date 2026-04-03
Primary Completion 2026-12-01 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-07