Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective, double-blind, randomized study of 2 infant formulas.
Exclusively formula-fed infants will participate in a 6-week feeding period of an infant formula. Tolerance records will be kept for 2 days at the end of the 6-week period by caregivers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine Infant Formula 1 | Active Comparator | Routine infant formula with probiotic |
|
| Routine Infant Formula 2 | Active Comparator | Routine infant formula with probiotic and prebiotic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine Infant Formula 1 | Other | Routine infant formula with probiotic |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Infant GI Symptom Burden | Study personnel will administer questionnaire | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Stool pattern | Caregivers will document on diary records | 6 weeks |
| Spit-up and/or vomiting pattern | Caregivers will document on diary records |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ryan Carvalho, MD | Nestle Nutrition | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avanza Medical Research Center | Pensacola | Florida | 32503 | United States | ||
| Bluegrass Clinical Research, Inc. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Routine Infant Formula 2 |
| Other |
Routine infant formula with probiotic and prebiotic |
|
| 6 weeks |
| Crying and fussing duration | Caregivers will document on diary records | 6 weeks |
| Formula intake | Caregivers will document on diary records | 6 weeks |
| Formula satisfaction questionnaire | Study personnel will administer questionnaire | 6 weeks |
| Weight (measured in grams) | Study personnel will measure | Enrollment and 6 weeks |
| Length (measured in centimeters) | Study personnel will measure | Enrollment and 6 weeks |
| Adverse events | Assessed throughout study | 2 weeks and 6 weeks |
| Louisville |
| Kentucky |
| 40291 |
| United States |
| PediaResearch | Owensboro | Kentucky | 42310 | 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 |
| Southwest Children's Research Associates | San Antonio | Texas | 78229 | United States |
| Tanner Clinic | Layton | Utah | 84041 | United States |