Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05848583
Status:
TERMINATED
Last Update Posted:
2023-12-13
First Post:
2023-04-05
Brief Title:
Nutritional Tolerance and Safety of a Tube Feeding Formula
Sponsor:
Société des Produits Nestlé SPN
Organization:
Société des Produits Nestlé SPN
Study Overview
Official Title:
A Single-Center Open-Label Study On The Nutritional Adequacy Tolerability And Safety Of A Standard Tube Feeding Formula In Adult Participants
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This open-label prospective study will be conducted to assess the nutritional efficacy safety and tolerance of a concentrated enteral formula in medically stable adults who currently require or will require to be enterally fed
Detailed Description:
In patients unable to meet energy and protein requirements orally enteral nutrition EN often serves as the sole source of nutrition for long-term tube fed individuals in varied care settings EN formulas are designed to meet patients macronutrient needs as well as vitamin and mineral needs with the overall objective of establishing and maintaining quality of life and further preventing undesirable outcomes that are associated with malnutrition Some individuals who might benefit from a formulation with real food ingredients have not been able to do so because they need a more concentrated higher calorie formula Compleat 15 is a calorically dense real food containing nutrition formula This open-label prospective study will be conducted to assess the nutritional efficacy safety and tolerance of a concentrated plant-based enteral formula with real food ingredients Compleat 15 in medically stable adults who currently require or will require to be enterally fed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2301CAHCN | OTHER | Sponsor | None |