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To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on symptoms of formula intolerance in healthy term infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infant formula supplemented with prebiotics | Experimental | infant formula powder, feed ad libitum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant formula supplemented with prebiotics | Other | Sole source nutrition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fussiness | Parent questionnaires | Change from baseline (3 days prior to study day 1) to within 1 day of initiation of study feeding |
| Measure | Description | Time Frame |
|---|---|---|
| Fussiness | Parent Questionnaires | Baseline to Day 29 |
| Hours of Daily Crying | Parent Questionnaires | Baseline to Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlene Borschel, PhD, RD, LD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeastern Pediatric Associates | Dothan | Alabama | 36305 | United States | ||
| Pensacola Research Consultants, Inc |
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| ID | Term |
|---|---|
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
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| Gastrointestinal Tolerance | Parent Questionnaires | Baseline to Day 29 |
| Stool Pattern | Parent Questionnaires | Baseline to Day 29 |
| Pensacola |
| Florida |
| 32503 |
| United States |
| Score Physician Alliance, LLC | St. Petersburg | Florida | 33710 | United States |
| Deaconess Clinic, Inc. | Evansville | Indiana | 47713 | United States |
| Kentucky Pediatric/Adult Research | Bardstown | Kentucky | 40004 | United States |
| Women's Clinic of Lincoln, PC | Lincoln | Nebraska | 68510 | United States |
| Aventiv Research | Grove City | Ohio | 43123 | United States |
| Coastal Pediatric Research | Charleston | South Carolina | 29414 | United States |
| Holston Medical Group | Bristol | Tennessee | 37620 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Southwest Children's Research Associates, P.A. | San Antonio | Texas | 78229 | United States |
| D011134 |
| Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |