Acceptability and Tolerance Study of Compleat®
Research type
Research Study
Full title
To evaluate the acceptability (including gastrointestinal tolerance and compliance) of an adult tube-feed formula with ingredients derived from food.
IRAS ID
308680
Contact name
Tanita Manton
Contact email
Sponsor organisation
Nestle Health Science
Duration of Study in the UK
0 years, 7 months, 30 days
Research summary
This is an acceptability study to evaluate the gastrointestinal tolerance over a seven-day period and compliance over one month for Compleat®. Compleat is a food for special medical purposes. The feed includes food derived ingredients. It is for children or adults who require an enteral feed for the dietary management of short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; feeding intolerances, developmental disabilities, disease related malnutrition.
Participants will be on the study formula for one month (28 days).
The study is of relevance to patients and healthcare professionals as it will provide data to be submitted from a minimum of 15 participants in order to apply to the Advisory Committee on Borderline Substances (ACBS) in the UK and the HSE submission for Ireland.
The Patients must be well established and stable on a standard enteral tube feed or on Isosource® Junior Mix (a paediatric standard tube feed with ingredients derived from food). The dietitian will determine the feeding regimen on an individual basis and the enteral formula will be provided via a feeding tube.Baseline questionnaire will be completed by a healthcare professional to capture current trends in gastrointestinal symptoms and medical history.
For 1 month, 15 participants replace their usual feed with Compleat®. They or their parent/caregiver complete a daily gastrointestinal tolerance diary for 7 days and formula intake for 4 weeks on usage, tolerance, acceptability, and compliance.
A brief questionnaire will be completed at the end of the study by the dietitian in order to assess any perceived changes to tolerance, compliance and patient satisfaction.
Once participants have completed the 28-day study product supply will stop and participants will return to their existing feeding regimen.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
22/SC/0004
Date of REC Opinion
24 Mar 2022
REC opinion
Further Information Favourable Opinion