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This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infant Formula supplemented with Oligosaccharides | Experimental | Ready to feed infant formula ; Feed ad libitum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant Formula supplemented with Oligosaccharides | Other | sole source nutrition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fussiness | Parent Questionnaires | Change from baseline (3 days prior to SD1) to within one day of initiation of study feeding (SD1) |
| Measure | Description | Time Frame |
|---|---|---|
| Fussiness | Parent Questionnaires | Baseline to SDAY 29 |
| Hours of daily crying | Parent Questionnaires | Baseline to SDAY 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlene Borschel, PhD, RD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | United States | ||
| Southeastern Pediatric Associates |
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| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| ID | Term |
|---|---|
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Gastrointestinal Tolerance | Parent Questionnaires | Baseline to SDAY 29 |
| Stool Pattern | Parent Questionnaire | Baseline to SDAY 29 |
| Dothan |
| Alabama |
| 36305 |
| United States |
| Watching Over Mothers and Babies | Tucson | Arizona | 85712 | United States |
| Norwich Pediatric Group, PC | Norwich | Connecticut | 06360 | United States |
| Florida Institute for Clinical Research, LLC | Orlando | Florida | 32825 | United States |
| Score Physician Alliance, LLC | St. Petersburg | Florida | 33710 | United States |
| Women's Clinic of Lincoln, PC | Lincoln | Nebraska | 68510 | United States |
| Institute of Clinical Research, LLC | Cleveland | Ohio | 44124 | United States |
| Aventiv Research | Grove City | Ohio | 43123 | United States |
| Coastal Pediatric Research | Charleston | South Carolina | 29414 | United States |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | United States |
| Southwest Children's Research Associates, P.A. | San Antonio | Texas | 78229 | United States |
| Tanner Clinic | Layton | Utah | 84041 | United States |