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Acceptability and Tolerance Market Research of a Slow Release, Phenylalanine-free Protein Substitute for the Dietary Management of Phenylketonuria
Sponsor: metaX Institut fuer Diatetik GmbH
Summary
XPhePiccosMR is a prospective, single-arm, open label, observational study that aims to evaluate the acceptability and tolerability of XPhe Piccos, a slow-release, phenylalanine-free protein substitute in the form of tiny tablets, for use in the dietary management of phenylketonuria (PKU) in children aged three years and older.
Official title: XPhe Piccos - Acceptability and Tolerance Market Research
Key Details
Gender
All
Age Range
3 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2026-10-01
Completion Date
2027-08-01
Last Updated
2026-09-03
Healthy Volunteers
No
Conditions
Interventions
Slow release, phenylalanine-free protein substitute tablets
Subjects who currently take a concentrated second stage phenylalanine-free protein substitute will be recruited. Subjects will take the study product for 7 days. Subjects will replace some or all of their usual protein substitute with the new product. The amount of study product prescribed will be calculated to provide the same amount of protein as their usual protein substitute.
Locations (1)
Birmingham Children´s Hospital
Birmingham, England, United Kingdom