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Extensively Hydrolyzed Formula Growth Monitioring Study (GMS)

NCT07513506 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2026-04-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Mead Johnson Nutrition

    lead INDUSTRY

Principal Investigators

  • Veronica Fabrizio, DO · Mead Johnson Nutrition

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Days
Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-03
Primary Completion
2026-12-01
Completion
2027-05-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07513506 on ClinicalTrials.gov