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The primary objective of this study is to assess the comparative gastrointestinal tolerance of normal term infants to two experimental milk-based powdered formulas compared with a standard milk-based powdered formula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1-Arm 1 Infant Formula | Experimental | Milk-based infant formula manufactured by an alternative method. Non-commercially available formula. To be fed ad libitum. |
|
| Phase 2- Arm 2 Infant Formula | Active Comparator | Milk-based infant formula using current manufacturing and ingredients. Non-commercially available formula. To be fed ad libitum. |
|
| Phase 2- Arm 3 Infant Formula | Experimental | Milk-based infant formula using a new protein. Non-commercially available formula. To be fed ad libitum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phase 1- Arm 1 Infant Formula | Other | Powder infant formula |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Stool consistency measured by Mean Rank Stool Consistency (MRSC) using parent reported diaries | MRSC will be calculated from data recorded on daily stool records during the study. Stool consistencies will be assigned the following: 1=watery, 2=loose/mushy, 3=soft, 4=formed, 5=hard. | Change from Study Day 1 to Study Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percentage of stools representing each stool consistency and color using parent reported diaries | Mean percentage of each recorded stool consistency (watery, loose/mushy, soft, formed, hard) and stool color (yellow, brown, green, black) will be calculated for each infant and then used to calculate for each group from daily data recorded on daily stool records during the study. | Change from Study Day 1 to Study Day 15 |
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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 |
|---|---|---|---|---|---|---|
| W.O.M.B Watching Over Mothers and Babies | Tucson | Arizona | 85712 | United States | ||
| SCORE Physician Alliance LLC |
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| Phase 2- Arm 2 Infant Formula |
| Other |
Powder infant formula |
|
| Phase 2- Arm 3 Infant Formula | Other | Powder infant formula |
|
| Mean predominant stool consistency and color measured using parent reported diaries | Mean predominant stool consistency and color for each infant calculated from data recorded on daily stool records during the study will be used to calculate the mean predominant stool consistency and color for each group. | Change from Study Day 1 to Study Day 15 |
| Average number of stools per day measured using parent reported diaries | Average number of stools/day will be calculated for each group from data recorded on daily stool records during the study. | Change from Study Day 1 to Study Day 15 |
| Mean percentages of feedings associated with spit-up and/or vomit measured using parent reported diaries. | Mean percentages of feedings associated with spit-up and/or vomiting will be calculated for each group from data recorded on daily formula intake records during the study. | Change from Study Day 1 to Study Day 15 |
| Parental responses to Formula Satisfaction and Infant Feeding and Stool Patterns Questionnaires | Parental responses to individual question on the Formula Satisfaction Questionnaire will be calculated from data recorded on the questionnaire at Study Day 15 | Change from Study Day 1 to Study Day 15 |
| Parental assessment of infant feeding and stool patterns measured by the Infant Feeding and Stool Patterns Questionnaire. | Parental responses to individual question on the Feeding and Stool Patterns Questionnaire will be calculated from data recorded on the questionnaire at Study Day 15. | Change from Study Day 1 to Study Day 15 |
| St. Petersburg |
| Florida |
| 33710 |
| United States |
| White Oak Family Physicians DBA/Asheboro Research Associates | Asheboro | North Carolina | 27203 | United States |
| Institute of Clinical Research, LLC | Mayfield Heights | Ohio | 44124 | United States |
| The Cleveland Pediatric Research Center, LLC | Middleburg Heights | Ohio | 44130 | United States |
| Tanner Memorial Clinic | Layton | Utah | 84041 | United States |