Market Research of a Slow Release Protein Substitute for the Dietary Management of PKU

Condition(s) studied

Investigational drug(s) / intervention(s)

Slow release, phenylalanine-free protein substitute tablets: The slow release, phenylalanine-free protein substitute in tablet form (XPhe Piccos) is a food for special medical purposes (FSMP) for use in the dietary management of Phenylketonuria or Hyperphenylalaninemia. The product is suitable from 3 years of age and over. XPhe Piccos are a highly concentrated phenylalanine-free protein supplement in the form of very small tablets/pellets enriched with vitamins, minerals and trace elements. XPhe Piccos are characterized by a prolonged release of the amino acids.

Study 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.

Eligibility

Primary outcome measure(s)

• Rate of patient compliance with consumption of the prescribed volume of study product — daily; from day 1 to day 7
  Compliance with the recommended intake of the usually prescribed protein substitute is assessed by the dietitian at baseline. Usage and compliance with the study product are recorded daily from day 1 to day 7 using a standardised form. Using the form, patients have to record the amount of the study product consumed in comparison to the prescribed doses. The reason for not consuming the full dose will be recorded by the patient/parent/caregiver as free text. Patients are asked to state whether the study product is easy to prepare with yes or no.

Trial sites (1)

Other trials for the same condition