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This is a randomized, controlled, double-blind, parallel, feeding study with the purpose to evaluate the tolerance of healthy term infants fed partially hydrolyzed whey protein infant formulas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Infant Formula | Active Comparator | Feed ad libitum |
|
| Experimental Infant Formula | Experimental | Feed ad libitum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Infant Formula | Other | Powdered partially hydrolyzed whey (WPH) based formula with an oligosaccharide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean rank stool consistency (MRSC) | Parent Completed Diary | Study Day 1 to 28 Days of Age |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Interval weight gain per day | 14 to 119 Days of Age |
| Gastrointestinal tolerance | Parent Completed Diary | 14 to 119 Days of Age |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Stool Characteristics | Parent Completed Diary | Study Day 1 to 119 Days of Age |
| Study Product Intake | Parent Completed Diary | Study Day 1 to 119 Days of Age |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Lasekan, PhD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visions Clinical Research | Tucson | Arizona | 85712 | United States | ||
| PAS Research, LLC |
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| Experimental Infant Formula | Other | Powdered partially hydrolyzed whey (WPH) based formula with oligosaccharides blend |
|
| Length | Interval length gain per day | 14 to 119 Days of Age |
| Head Circumference | Interval head circumference gain per day | 14 to 119 Days of Age |
| Infant and Household Characteristics | Parent reported lifestyle and illness questions | Study Day 1 to 119 Days of Age |
| Health Resource Utilization | Number of Visits | Study Day 1 to 119 Days of Age |
| Infant Feeding and Stool Patterns Questionnaire | Parent completed questionnaire; 16, 5-point Likert scale questions, scaled in the negative direction | Exit or 119 Days of Age |
| Infant Behavior Questionnaire | Parent completed questionnaire; 22 questions with 5-point Likert scale questions; scaled in the negative direction | Exit or 119 Days of Age |
| Formula Satisfaction Questionnaire | Parent completed questionnaire; 13 questions of up to 5 categories scaled in the negative direction | Exit or 119 Days of Age |
| Adverse Events | Standard adverse event reporting | Study Day 1 to 119 Days of Age |
| Tampa |
| Florida |
| 33613 |
| United States |
| Springs Medical Research | Owensboro | Kentucky | 43203 | United States |
| Institute of Clinical Research | Mentor | Ohio | 44060 | United States |
| The Cleveland Pediatric Research Center, LLC | Westlake | Ohio | 44145 | United States |
| Midsouth Center for Clinical Research | Memphis | Tennessee | 38116 | United States |