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The study objective is to assess the growth, tolerance and efficacy of a complete amino acid-based medical food in children with chronic diarrhea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Infant Formula | Experimental | Complete peptide 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 |
|---|---|---|
| Physician determined target outcome | Outcome dependent on individual subject assessment and may include decreased stool number, decreased vomiting, decreased gas, weight gain, increased caloric intake, increased protein intake, increased serum albumin concentration, increased hemoglobin concentration, better acceptance of supplemental formula. | Study Day (SD)1-84 |
| 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 |
| Gastro-Intestinal Tolerance | Parent reported record of incidence of regurgitation. |
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Inclusion Criteria:
Exclusion Criteria:
- Any non-approved concomitant study
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| Name | Affiliation | Role |
|---|---|---|
| Marlene Borschel, PhD, RD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Johns Hopkins Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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) 2-4, 5-7, 25-27, 81-83 |
| Stool characteristics | Parent completed diary of stool consistency, frequency/volume. | Study Day (SD) 2-4, 5-7, 25-27 and 81-83 |
| Blood Chemistry | Hemoglobin, hematocrit, serum albumin, total protein, urea nitrogen, alkaline phosphatase | Study Day (SD) 1 and 84 |
| Anthropometrics | Weight and length | Study Day (SD) 1, 28 and 84 |
| Baltimore |
| Maryland |
| 21287 |
| United States |