NCT06102122

Acceptability and Tolerance Study of Adult Tube Feed with Food with Food Derived Ingredients.

To Evaluate the Acceptability (including Gastrointestinal Tolerance and Compliance) of an Adult Tube-feed Formula with Ingredients Derived from Food.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

Product acceptability data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the Health Service Executive (HSE) submission for Ireland for product registration.

Detailed description

To evaluate the acceptability (including gastrointestinal tolerance and compliance) of an adult tube-feed formula with ingredients derived from food for the dietary management of participants who require a tube feed. . The acceptability data from 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the Health Service Executive (HSE) for Ireland. Participants will be provided with one month supply of 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 volumes

Conditions

• Dietary Exposure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Compleat	Patients well established and stable on a standard enteral tube feed with food derived ingredients will act as their own controls and make a product switch

Timeline

• Start date: 2023-08-22
• Primary completion: 2023-09-15
• Completion: 2023-12-22
• First posted: 2023-10-26
• Last updated: 2024-09-23

Locations

1 site across 1 country: United Kingdom