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Infants with protein sensitive colitis fed a nutritionally complete free amino acid-based medical food will be evaluated for 42 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Infant Formula | Experimental | Experimental formula to be fed ad libitum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Infant Formula | Other | Nutritionally complete free amino acid-based medical food. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician Rated Symptom Score | Calculated from a symptom checklist based on parent report of the previous 7 day history; Change in physician rated symptom score from SD 1 to SD 43. | Study Day (SD) 1 and 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Rank Stool Consistency | Parent reported stool records | Study Day (SD) 2-4 and 40-42 |
| Weight | Weight gain during the feeding period |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlene Borschel, PhD, RD | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States | ||
| Children's Hospital |
| 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. |
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| Study Day (SD) 1 and 43 Visits |
| Formula Intake | Parent reported records of formula intake | Study Day (SD) 2-4 and 40-42 |
| Daily Stool Number | Parent reported stool records | Study Day (SD) 2-4 and 40-42 |
| Stool Occult Blood | Parent collected sample of infant stool | Study Day (SD) 2-4 and 40-42 |
| Omaha |
| Nebraska |
| 68114 |
| United States |