Trials / Terminated
TerminatedNCT05429853
TOLER-ENT Study: A Study to Investigate the Tolerance of the High Energy, High Protein Formula Sondalis® HP 2 kcal
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Société des Produits Nestlé (SPN) · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Sondalis® HP 2 kcal (with or without fibre) | The participants will take the study product during the two months of the study. |
Timeline
- Start date
- 2022-07-08
- Primary completion
- 2024-05-28
- Completion
- 2024-05-28
- First posted
- 2022-06-23
- Last updated
- 2025-12-19
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT05429853. Inclusion in this directory is not an endorsement.