TYR EASY Shake & Go - ACCEPTABILITY AND TOLERANCE
Research type
Research Study
Full title
TYR EASY Shake & Go - ACCEPTABILITY AND TOLERANCE
IRAS ID
224960
Contact name
Anita MacDonald
Contact email
Sponsor organisation
Galen Ltd
Duration of Study in the UK
0 years, 3 months, 0 days
Research summary
The principle treatment for children with Tyrosinaemia (TYR) is a low protein diet. Part of this treatment requires the administration of a protein substitute. Several brands of protein substitutes are already available in the UK in various
presentations. However, compliance with taking protein substitutes continues to be a challenge. As a low protein diet is recommended for life, long term compliance is a growing concern. As a result, improving the choice in terms of product type may aid compliance.
This is a prospective, observational market research study in 15 children with PKU to evaluate the acceptability, tolerance and compliance with PKU-Go, a protein substitute for use in the dietary management of children with PKU over the age of 9 months.
Subjects who are currently taking a protein substitute for PKU will be recruited for a 14-day trial of the new protein substitute to evaluate the tolerability and acceptability of the study product.
During the 14-day trial caregivers will be asked to complete a daily questionnaire recording information on:
• Usage and compliance
• Ease of use and any issues with administration
• Any gastro-intestinal side-effects.
A questionnaire will also be completed at the beginning and end of the study that will consider perceptions about taste, appearance, smell, presentation and packaging of the product; ease of administration; how it is taken; and any other problems or symptoms.
The outcome of this assessment will be used in a submission to regulatory authorities to get the study product reimbursable on prescription in the UK.REC name
London - London Bridge Research Ethics Committee
REC reference
18/LO/1966
Date of REC Opinion
19 Nov 2018
REC opinion
Favourable Opinion