BIG Study (Brain, Immune, and Gut Health Evaluation of Infants/Young Children Fed Infant Formula, and Later Supplemental Toddler Nutrition, With 5 Specific HMOs)
Public ClinicalTrials.gov record NCT04957992. 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
Infant Formula and Toddler Drink Feeding Intervention Through 24 Months of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the growth and development outcomes of infants fed a new infant formula and toddler drink through 24 months of age.
Study identification
- NCT ID
- NCT04957992
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 607 participants
Conditions and interventions
Conditions
Interventions
- Control Infant Formula Other
- Control Toddler Drink Other
- Experimental Infant Formula Other
- Experimental Toddler Drink Other
- Human Milk Other
- Human Milk Supplemental Formula Other
- Human Milk Toddler Drink Other
Other
Eligibility (public fields only)
- Age range
- 0 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
- Jul 21, 2021 (Actual)
- Primary completion
- May 12, 2025 (Actual)
- Completion
- May 12, 2025 (Actual)
- Last update posted
- Jun 27, 2025
2021 – 2025
United States locations
- U.S. sites
- 42
- U.S. states
- 18
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| MedPharmics, LLC 3192 | Phoenix | Arizona | 85015 | — |
| HealthStar Research | Glenwood | Arkansas | 71943 | — |
| HealthStar Research, LLC | Hot Springs | Arkansas | 71913 | — |
| The Children's Clinic of Jonesboro, P.A. | Jonesboro | Arkansas | 72401 | — |
| Applied Research Center of Arkansas | Little Rock | Arkansas | 72019 | — |
| Optumcare Colorado Springs, LLC | Colorado Springs | Colorado | 80922 | — |
| Boeson Research 3266 | Grand Junction | Colorado | 81505 | — |
| TOPAZ Clinical Research, Inc. | Apopka | Florida | 32703 | — |
| Columbus Clinical Services, LLC. | Miami | Florida | 33125 | — |
| Emerald Coast OBGYN Clinical Research | Panama City | Florida | 32405 | — |
| ASCLEPES Research Centers | Spring Hill | Florida | 34609 | — |
| Jedidiah Clinical Research | Tampa | Florida | 33617 | — |
| Meridian Clinical Research 3259 | Macon | Georgia | 31210 | — |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | — |
| Leavitt Clinical Research | Idaho Falls | Idaho | 83404 | — |
| Qualmedica Research | Evansville | Indiana | 47715 | — |
| Deaconess Clinic, Inc. | Evansville | Indiana | 47725 | — |
| Qualmedica Research, LLC | Owensboro | Kentucky | 42301 | — |
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | — |
| MedPharmics, LLC 3343 | Covington | Louisiana | 70433 | — |
| MedPharmics Research 3369 | Slidell | Louisiana | 70458 | — |
| Boeson Research 3367 | Great Falls | Montana | 59405 | — |
| Boeson Research 3265 | Kalispell | Montana | 59901 | — |
| Boeson Research 3267 | Missoula | Montana | 59804 | — |
| Meridian Clinical Research 3264 | Grand Island | Nebraska | 68803 | — |
| Meridian Clinical Research 3263 | Hastings | Nebraska | 68901 | — |
| Meridian Clinical Research 3304 | Lincoln | Nebraska | 68510 | — |
| Alivation Research | Lincoln | Nebraska | 68526 | — |
| University of Nebraska Medical Center 3315 | Omaha | Nebraska | 68117 | — |
| University of Nebraska Medical Center 3314 | Omaha | Nebraska | 68131 | — |
| Advantage Clinical Trials | The Bronx | New York | 10468 | — |
| Ohio Pediatric Research Association | Dayton | Ohio | 45414 | — |
| Tribe Clinical Research LLC 3313 | Greenville | South Carolina | 29607 | — |
| Tribe Clinical Research LLC 3382 | Spartanburg | South Carolina | 29301 | — |
| Coastal Pediatric Research | Summerville | South Carolina | 29486 | — |
| Holston Medical Group 3301 | Bristol | Tennessee | 37620 | — |
| Holston Medical Group 3046 | Kingsport | Tennessee | 37660 | — |
| AVIATI Healthcare & Clinical Research | Memphis | Tennessee | 38115 | — |
| Javara Inc. 3377 | Dallas | Texas | 75230 | — |
| Maximos Ob/Gyn | League City | Texas | 77573 | — |
| National Clinical Research, Inc | Richmond | Virginia | 23294 | — |
| Multicare Health System - Rockwood Pediatrics | Spokane | Washington | 99202 | — |
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 NCT04957992, 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 Jun 27, 2025 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04957992 live on ClinicalTrials.gov.