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This is a Multicenter, Open-label, Single-arm study evaluating the Tolerance and Safety of a Peptide-based Enteral Formula with Partially Hydrolyzed Guar Gum (PHGG) in the Nutritional Management of Tube-fed Children Aged 1-4 Years over a 7 day period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enteral formula tube feeding | Experimental | Enterally fed children, ages 1-4, with established enteral feeding access |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteral Formula With (PHGG) | Other | Pediatric subjects will be fed a Peptide-based Enteral Formula With Partially Hydrolyzed Guar Gum (PHGG) |
|
| Measure | Description | Time Frame |
|---|---|---|
| GI Intolerance | Occurrence of gastrointestinal intolerance (yes/no) | 7 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Frequency and nature of adverse events | 7 Days |
| Energy Requirements Met | The daily percentage of energy requirements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Minor, MMS, PA-C | Children's Center for GI and Nutrition | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Center for GI and Nutrition | Hollywood | Florida | 33021 | United States | ||
| The University of Chicago Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37202073 | Derived | Minor G, Sentongo T, Heine RG, Zemrani B. Tolerability and safety of a semi-elemental enteral formula with partially hydrolyzed guar gum (PHGG) in tube-fed children aged 1-4 years: An open-label, single-arm study. Clin Nutr ESPEN. 2023 Jun;55:392-399. doi: 10.1016/j.clnesp.2023.04.004. Epub 2023 Apr 21. |
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| 7 Days |
| Change in Weight | The change in weight over a 7-day period | 7 Days |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Riley Children's Hospital | Indianapolis | Indiana | 46202 | United States |
| The Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| University of Utah Health Care - Huntsman Cancer Institute (HCI) | Salt Lake City | Utah | 84113-1125 | United States |