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This is a prospective, open-label single-arm observational clinical trial to assess enteral feeding nutrition goals with a peptide-based, high protein enteral formula.
This is a prospective, observational study to assess the ability to meet enteral nutrition goals and tolerance of a peptide-based, high protein tube feeding product in adult, tube-fed patients living in the community setting. In addition, the study will explore metabolic and inflammatory markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enteral Tube-fed Adults | Other | Adults being fed an enteral formula with a feeding tube |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Food: Peptide-Based Enteral Formula | Other | Will be fed exclusively the study peptide-based, high protein enteral formula via a feeding tube |
|
| Measure | Description | Time Frame |
|---|---|---|
| Calorie nutritional goals | Daily percentage of calorie nutritional goals met | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Protein nutritional goals | Daily percentage of protein nutritional goals met | 14 days |
| Daily reports of gastrointestinal intolerance | Daily occurrence of nausea, stool frequency, stool consistency, and/or vomiting) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krysmaru Araujo Torres, MD | Nestle Health Science | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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Prospective, single-arm, non-randomized, open-label observational study
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| 14 days |
| Adverse events | Daily adverse event reporting | 14 days |