Extensively Hydrolyzed Formula Growth Monitioring Study (GMS)
Public ClinicalTrials.gov record NCT07513506. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
GROWTH AND TOLERANCE OF A NEW INFANT FORMULA USING AN EXTENSIVELY HYDROLYZED CASEIN-BASED PROTEIN (eHCF)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07513506
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 214 participants
Conditions and interventions
Conditions
Interventions
- Extensively hydrolyzed casein formula (C-eHCF), commercially available Other
- Extensively hydrolyzed casein formula (INV-eHCF) Other
Other
Eligibility (public fields only)
- Age range
- 10 Days to 14 Days
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 3, 2026 (Estimated)
- Primary completion
- Dec 1, 2026 (Estimated)
- Completion
- May 1, 2027 (Estimated)
- Last update posted
- Apr 7, 2026
2026 – 2027
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics | Birmingham | Alabama | 35235 | — |
| Childrens Clinic of Jonesboro | Jonesboro | Arkansas | 72401 | — |
| SPRIM | Harbor Beach | Florida | 32937 | — |
| Symphony Research | Jacksonville | Florida | 32224 | — |
| Hope Research Network | Virginia Gardens | Florida | 33166 | — |
| Mid Valley Research Inc. | Moline | Illinois | 61265 | — |
| Springs Medical Research | Owensboro | Kentucky | 42303 | — |
| InnovoResearch | Wilmington | North Carolina | 28405 | — |
| AVIATI Healthcare & Clinical Research | Memphis | Tennessee | 38115 | — |
| NeutraLife Science | Richmond | Texas | 77469 | — |
| AMR | Syracuse | Utah | 84075 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07513506, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 7, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07513506 live on ClinicalTrials.gov.