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This clinical trial will determine if the formula given to infants experiencing fussiness, crying, cramping, gas, and/or diarrhea, is accepted and well tolerated and helps to resolve symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Marketed milk-based lactose-containing infant formula | Other |
| |
| Marketed milk-based lactose-free infant formula | Other |
| |
| Marketed soy-based lactose-free infant formula | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marketed milk-based lactose-containing infant formula | Other |
| ||
| Marketed milk-based lactose-free infant formula |
| Measure | Description | Time Frame |
|---|---|---|
| Early Infant Temperament Questionnaire | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Characteristic Questionnaire | 14 days | |
| Maternal Efficacy Questionnaire | 14 days | |
| Mental Health Inventory Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colin Rudolph, M.D., Ph.D | Mead Johnson & Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Mark Pearlman | Aurora | California | 80011 | United States | ||
| Gould Medical Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25643020 | Derived | Sherman AL, Anderson J, Rudolph CD, Walker LS. Lactose-Free Milk or Soy-Based Formulas Do Not Improve Caregivers' Distress or Perceptions of Difficult Infant Behavior. J Pediatr Gastroenterol Nutr. 2015 Jul;61(1):119-24. doi: 10.1097/MPG.0000000000000743. |
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| Other |
|
| Marketed soy-based lactose-free infant formula | Other |
|
| 14 days |
| Modesto |
| California |
| 95355 |
| United States |
| Memorial Medial Center Research | Savannah | Georgia | 31405 | United States |
| Welborn Clinic Peds | Evansville | Indiana | 47713 | United States |
| Riveria Pediatrics | Indianapolis | Indiana | 46254 | United States |
| Kentucky Pediatrics | Bardstown | Kentucky | 40004 | United States |
| Kids Med South | Baton Rouge | Louisiana | 70820 | United States |
| The Pediatric Group | Princeton | New Jersey | 08540 | United States |
| Chapel Hill Pediatrics | Durham | North Carolina | 27713 | United States |
| Henderson Pediatrics | Fletcher | North Carolina | 28732 | United States |
| Matthews Children Group | Matthews | North Carolina | 28105 | United States |
| Capital Pediatrics | Raleigh | North Carolina | 27609 | United States |
| Pediatric Medical Associates | Havertown | Pennsylvania | 19083 | United States |
| Pennridge Pediatrics | Sellersville | Pennsylvania | 18960 | United States |
| Pittsburgh Pediatric Research | Upper Saint Clair | Pennsylvania | 15241 | United States |
| Lewis Gale Clinic | Salem | Virginia | 24153 | United States |
| Vancouver Clinic | Vancouver | Washington | 98664 | United States |
| Rhinelander Medical Center | Rhinelander | Wisconsin | 54501 | United States |
| Dr. David Conner | Winnipeg | Manitoba | Canada |