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The study objective is to assess the growth of infants fed an experimental formula for the nutritional management of chronic diarrhea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Infant Formula | Experimental | Complete amino acid-based infant formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Infant Formula | Other | Infant formula to be fed ad libitum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Change in weight from baseline. | Study Day (SD) 1, 28 and 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Stool Characteristics | Parent completed diary of stool consistency, frequency/volume. | Study Day (SD) 2-4, 5-7, 25-27 and 81-83 |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary Assessment | Parent completed record of infant dietary intake. | Study day (SD) 2-4, 5-7, 25-27 and 81-83 |
| Blood Chemistry | Hemoglobin, hematocrit, serum albumin, total protein, urea nitrogen, alkaline phosphatase |
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 |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States | ||
| Children's Hospital of Detroit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33006765 | Derived | Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2. | |
| 24885833 | Derived | Borschel MW, Antonson DL, Murray ND, Oliva-Hemker M, Mattis LE, Kerzner B, Tolia V, Baggs G. Two single group, prospective, baseline-controlled feeding studies in infants and children with chronic diarrhea fed a hypoallergenic free amino acid-based formula. BMC Pediatr. 2014 May 29;14:136. doi: 10.1186/1471-2431-14-136. |
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| Study Day (SD) 1 and 84 |
| Physician Assessment of Abdominal Complaints | Individualized per subject, may include decreased vomiting, stool number or volume or increased weight gain. | Study Day (SD) 1, 28 and 84 |
| Detroit |
| Michigan |
| 48201 |
| United States |
| Children's Hospital | Omaha | Nebraska | 68114 | United States |