PKU Go - ACCEPTABILITY AND TOLERANCE
Research type
Research Study
Full title
PKU Go - ACCEPTABILITY AND TOLERANCE
IRAS ID
222476
Contact name
Anita MacDonald
Contact email
Sponsor organisation
Galen Ltd
Duration of Study in the UK
0 years, 0 months, 15 days
Research summary
The principle treatment for children with Phenylketonuria (PKU) 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\npresentations. 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.\nThis 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.\nSubjects 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.\nDuring the 14-day trial caregivers will be asked to complete a daily questionnaire recording information on:\n• Usage and compliance\n• Ease of use and any issues with administration\n• Any gastro-intestinal side-effects.\nA 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.\nThe 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
South West - Frenchay Research Ethics Committee
REC reference
17/SW/0085
Date of REC Opinion
13 Jun 2017
REC opinion
Further Information Favourable Opinion