Extensively Hydrolyzed Formula Growth Monitioring Study (GMS) (NCT07513506) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Extensively Hydrolyzed Formula Growth Monitioring Study (GMS)
United States214 participantsStarted 2026-04-03
Plain-language 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.
Who can participate
Age range
10 Days – 14 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 wit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.