PEMP-AT v1

• Research type

  Research Study

• Full title

  PKU EASY Microtabs Plus - ACCEPTABILITY AND TOLERANCE

• IRAS ID

  320040

• Contact name

  Anita MacDonald

• Contact email

  anita.macdonald@nhs.net

• Sponsor organisation

  Galen Ltd

• Duration of Study in the UK

  0 years, 2 months, 0 days

• Research summary

  The principle treatment for people 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
  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 10 people with PKU to evaluate the acceptability, tolerance and compliance with PKU EASY Microtabs Plus, a protein substitute for use in the dietary management of patients with PKU from 3 years and above. It is an improved version of the current PKU EASY Microtabs, with vitamins and minerals added to the new Plus version.
  Subjects who are currently taking a protein substitute for PKU will be recruited for a 7-day trial of the new protein substitute to evaluate the tolerability and acceptability of the study product.
  During the 7-day trial patients or caregivers(depending on ability) 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

  East of England - Cambridge South Research Ethics Committee

• REC reference

  24/EE/0184

• Date of REC Opinion

  8 Oct 2024

• REC opinion

  Further Information Favourable Opinion