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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
18
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
Tanita Flood
London, United Kingdom
Daily record via participant diary
Daily Gastrointestinal diary as questionnaire, increase, decrease or no change
Time frame: 7 days
Formula intake diary
mL per day
Time frame: 28 days
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