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To assess the effects of infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Infant Formula | Experimental | Feed ad libitum during study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study Infant Formula | Other | RTF milk-based infant formula with oligosaccharides |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fussiness | Absolute and % change in fussiness severity reported from Daily Tolerance Diary | Baseline to Study Day (SDAY) 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Tolerance | Parent Completed Diary | Baseline to SDAY 28 |
| Stool | Parent Completed Diary | Baseline to SDAY 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Formula Intake | Parent Completed Diary | SDAY 1 to SDAY 28 |
| Weight | Weight gains, percentiles, and z-scores | SDAY 1 to SDAY 28 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Reverri, PhD, MS, RD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedPharmics, LLC | Phoenix | Arizona | 85015 | United States | ||
| Dade Research Center, LLC |
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| Length | Length gains, percentiles, and z-scores | SDAY 1 to SDAY 28 |
| Infant Feeding and Stool Patterns Questionnaire | Parent completed questionnaire; 16, 5-point Likert scale questions, scaled from frequent to less frequent | SDAY 1 and SDAY 28 |
| Formula Satisfaction Questionnaire | Parent completed questionnaire; 13 questions of up to 5 categories scaled from positive to negative | SDAY 1 and SDAY 28 |
| Parental perspectives | Parent completed questionnaire; 4, 5-point Likert scale questions, scaled from negative to positive | SDAY 1 and SDAY 28 |
| Health Resource Utilization | Number of Visits | SDAY 7 and SDAY 28 |
| Adverse Events | Standard adverse event reporting | SDAY 1 to SDAY 28 |
| Miami |
| Florida |
| 33126 |
| United States |
| Meridian Clincial Research- Macan | Macon | Georgia | 31210 | United States |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | United States |
| Springs Medical Research | Owensboro | Kentucky | 42303 | United States |
| MedPharmics | Covington | Louisiana | 70433 | United States |
| Boeson Research Kalispell | Kalispell | Montana | 59901 | United States |
| Meridian Clinical Research | Hastings | Nebraska | 68901 | United States |
| Be Well Clinical Studies | Lincoln | Nebraska | 68516 | United States |
| AVIATI Healthcare & Clinical Research | Memphis | Tennessee | 38115 | United States |
| Invesclinic US LLC | Edinburg | Texas | 78539 | United States |
| Maximos Ob/Gyn | League City | Texas | 77573 | United States |