NCT07513506

Extensively Hydrolyzed Formula Growth Monitioring Study (GMS)

GROWTH AND TOLERANCE OF A NEW INFANT FORMULA USING AN EXTENSIVELY HYDROLYZED CASEIN-BASED PROTEIN (eHCF)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: Mead Johnson Nutrition · Industry
• Sex: All
• Age: 10 Days – 14 Days
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
OTHER	Extensively hydrolyzed casein formula (C-eHCF), commercially available	A commercially available extensively hydrolyzed casein formula
OTHER	Extensively hydrolyzed casein formula (INV-eHCF)	An extensively hydrolyzed casein formula

Timeline

• Start date: 2026-04-03
• Primary completion: 2026-12-01
• Completion: 2027-05-01
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

12 sites across 1 country: United States