NCT06034951

Acceptability and Tolerance Study of a High Energy Tube Feed with Food Derived Ingredients

Acceptability (including Gastrointestinal Tolerance and Compliance) of a High Energy, Adult Enteral Formula with Food-derived Ingredients.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

Enterally fed adults and children who are assessed by the dietitian as requiring an adult high-energy, fibre-containing enteral formula will be recruited. Data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) for product registration.

Detailed description

To evaluate the acceptability (including gastrointestinal tolerance and compliance) of a high energy, adult enteral formula with food-derived ingredients.This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a 14-day period with the new tube feed. Participants or their caregivers will be provided with 14-day supply of the new tube feed and will be asked to complete a daily diary and short questionnaire to record information allowing assessment of the following: * Gastrointestinal tolerance * Compliance with prescribed feed volume

Conditions

• Tolerance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Compleat 1.5 HP	Patients well established and stable on an enteral tube feed. This group will act as their own controls and switched to the new tube feed.

Timeline

• Start date: 2023-05-24
• Primary completion: 2023-08-21
• Completion: 2023-12-22
• First posted: 2023-09-13
• Last updated: 2024-09-23

Locations

1 site across 1 country: United Kingdom