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Understand the impact of switching to a commercially available infant formula on gastrointestinal symptoms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Routine infant formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine infant formula | Other | Routine infant formula with probiotic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infant GI Symptom Burden | Study personnel will administer questionnaire | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Formula Intake | Caregivers will document on diary records | 24 hours |
| Fussiness | Caregivers will document on diary records | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Carvalho, MD | Nestle Nutrition | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwich Pediatrics Group | Norwich | Connecticut | 06360 | United States | ||
| Qualmedica Research |
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Subjects and their parent/caregiver will be blinded to the intervention product. Care Providers at sites, Investigators, and Outcomes Assessors are unblinded to the intervention product.
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| Formula Satisfaction Questionnaire | Study personnel will administer questionnaire | 3 weeks |
| Adverse Events | Assessed throughout study | 24 hours and 3 weeks |
| Owensboro |
| Kentucky |
| 42301 |
| United States |
| Ohio Pediatric Research Association | Dayton | Ohio | 45414 | United States |
| Coastal Pediatric Associates | Charleston | South Carolina | 29414 | United States |
| Midsouth Center for Clinical Research, LLC | Memphis | Tennessee | 38116 | United States |
| ClinPoint Trials | Waxahachie | Texas | 75165 | United States |
| Tanner Clinic | Layton | Utah | 84041 | United States |