Zero minis Market Research_V1

• Research type

  Research Study

• Full title

  Zero minis - Acceptability and Tolerance Market Research

• IRAS ID

  302758

• Contact name

  Anita MacDonald

• Contact email

  anita.macdonald@nhs.net

• Sponsor organisation

  metaX Institut fuer Diaetetik GmbH

• Duration of Study in the UK

  1 years, 11 months, 31 days

• Research summary

  This is a prospective, multicentre, observational market research study with the aim to review a total of 15 children with rare metabolic disorders representing TYROSINAEMIA TYPE I, II, III or ALKAPTONURIA, HOMOCYSTINURIA and MAPLE SYRUP URINE DISEASE.

  Subjects who are currently taking a protein substitute will be recruited for a 7-days trial of the new range of ready-to-use protein substitute tablets to evaluate the tolerability and acceptability of the study products.

  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

  West Midlands - Black Country Research Ethics Committee

• REC reference

  23/WM/0213

• Date of REC Opinion

  14 Nov 2023

• REC opinion

  Further Information Favourable Opinion