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

Tolerance Clinical Trial

Official title:
Acceptability (Including Gastrointestinal Tolerance and Compliance) of a High Energy, Adult Enteral Formula With Food-derived Ingredients.

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06034951
Study type Interventional
Source Société des Produits Nestlé (SPN)
Contact
Status Completed
Phase N/A
Start date May 24, 2023
Completion date December 22, 2023
View Details
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