Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05429853
Status:
RECRUITING
Last Update Posted:
2023-12-07
First Post:
2022-06-02
Brief Title:
TOLER-ENT Study A Study to Investigate the Tolerance of the High Energy High Protein Formula Sondalis HP 2 kcal
Sponsor:
Société des Produits Nestlé SPN
Organization:
Société des Produits Nestlé SPN
Study Overview
Official Title:
TOLER-ENT Study A Study to Investigate the Tolerance of the High Energy High Protein Formula Sondalis HP 2 kcal
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SONDALIS
Brief Summary:
A multicentre prospective open-label single arm study for 2 months involving adult patients under poorly tolerated Home Enteral Nutrition HEN The study aims to analyse the evolution of tolerance and quality of life of HEN patients after switching from a High Protein High Energy HPHE polymeric Enteral Nutrition EN formula with or without fibre to Sondalis HP 2kcal with or without fibre Eligible patients will give their written consent to participate before being included into the study
Detailed Description:
None
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