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This clinical trial will evaluate an investigational infant formula with a probiotic to determine if it provides normal growth and if it is well tolerated by term infants compared to a marketed routine infant formula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Marketed routine infant formula | Active Comparator |
| |
| Infant formula containing a probiotic source | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| An investigational infant formula containing a probiotic source | Other |
| ||
| Control: Marketed routine infant formula |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight measured at each study visit | 3.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recall of infant formula intake at each study visit | 3.5 months | |
| Body length measured at each study visit | 3.5 months | |
| Recall of stool consistency measured at each study visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol Lynn Berseth, M.D. | Mead Johnson Nutrition | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Pediatric Associates | Birmingham | Alabama | 35205 | United States | ||
| Greenvale Pediatrics Hoover |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39507493 | Derived | Berseth CL, Yeiser M, Harris CL, Kinnaman JN, Lappin V, Wampler JL, Zhuang W, Vanderhoof J. Infant formula with added Lacticaseibacillus rhamnosus GG supported adequate growth and was well tolerated in healthy term infants: a randomized controlled trial. Front Pediatr. 2024 Oct 23;12:1456607. doi: 10.3389/fped.2024.1456607. eCollection 2024. |
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| Other |
|
| 3.5 months |
| Medically-confirmed adverse events collected throughout the study period | 3.5 months |
| Parental Study Product Assessment Questionnaire completed at Study Visit 2 | once |
| Head circumference measured at each study visit | 3.5 months |
| Recall of gastrointestinal tolerance measured at each study visit | 3.5 months |
| Birmingham |
| Alabama |
| 35244 |
| United States |
| Southeastern Pediatric Associates | Dothan | Alabama | 36305 | United States |
| Pediatrics East - Alabama Clinical Therapeutics | Pinson | Alabama | 35126 | United States |
| The Children's Clinic of Jonesboro, P.A. | Jonesboro | Arkansas | 72401 | United States |
| Arkkansas Pediatric Clinic | Little Rock | Arkansas | 72205 | United States |
| Norwich Pediatric Group, P.C. | Norwich | Connecticut | 06360 | United States |
| Children's Research, LLC | Altamonte Springs | Florida | 32701 | United States |
| Children's Medical Associations | Plantation | Florida | 33324 | United States |
| Deaconess Clinical Research | Evansville | Indiana | 47713 | United States |
| Owensboro Pediatrics | Owensboro | Kentucky | 42303 | United States |
| Woburn Pediatic Associates | Woburn | Massachusetts | 01801 | United States |
| Cary Pediatric Center, P.A. | Cary | North Carolina | 27518 | United States |
| Capital Pediatrics & Adolescent Center | Raleigh | North Carolina | 27609 | United States |
| Pediatric Associates of Mt. Carmel, Inc | Cincinnati | Ohio | 45245 | United States |
| Pediatric Associates of Fairfield, Inc. | Fairfield | Ohio | 45014 | United States |
| Parma Pediatrics, Inc | Parma | Ohio | 44129 | United States |
| UHMP Comprehensive Pediatrics | Westlake | Ohio | 44145 | United States |
| The Jackson Clinic - North Jackson | Jackson | Tennessee | 38305 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Austin Diagnostic Clinic | Austin | Texas | 78749 | United States |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | United States |