PKU Microtablets Case Studies

Starting soon · Not applicable

Conditions studied: Phenylketonuria (PKU)

In brief

Phenylalanine (Phe) free protein substitutes are typically presented in ready to drink liquid or powder format and are made up with water to a set volume. Despite recent advancements related to the taste, scent and texture of commercially available protein substitutes, a proportion of PKU patients choose to consume tablet-based protein substitutes. Protein substitutes in tablet format may help overcome taste, scent and texture concerns associated with powdered and liquid preparations. Indeed, previous research has shown that protein substitute tablets are an effective strategy to manage PKU in children, teenagers and adults. Nonetheless, the daily burden and discipline required often impedes compliance, especially alongside the restrictive low-protein diet. Achieving compliance with multivitamin supplements when given alongside protein substitutes therefore becomes especially challenging. This is particularly true for adolescent, adult and maternal populations. PKU Microtablets have recently been developed. PKU Microtablets are a new phenylalanine-free tablet protein substitute combined with vitamins, minerals and trace elements. As patient acceptability is fundamental to the successful use of any protein substitute, investigation is needed to assess the compliance, tolerance and acceptability of PKU Microtablets as part of a low phenylalanine dietary regimen in PKU patients. This series of case-studies aims to evaluate the gastrointestinal tolerance, acceptability, compliance, and safety of this protein substitute in both adults and children from 4 years. These case studies will last 29 days in total, including a 1-day baseline period followed by a 28-day intervention period. The case studies will be conducted across multiple specialist metabolic centres in the UK.

Key facts

Study ID: NCT07671859
Run by: Nutricia UK Ltd
People needed: 20
Starts: 2026-07-01
Expected to finish: 2027-07-01
Last updated by the study team: 2026-06-26

Who can join

Age: 4 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female
Over 4 years of age
Patients diagnosed with any phenotype of PKU characterised by hyperphenylalaninaemia
Have been compliant in taking at least one protein substitute, providing at least 20g protein equivalent, for at least 1 month prior to trial commencement
Have a prescribed daily phenylalanine allowance for PKU
Written or electronic informed consent from patient, and/or from parent/caregiver if applicable
Participants who are anticipated to be able to take at least 20g protein equivalent of the case study product per day

You may not qualify if…

Pregnant or lactating
Requiring parenteral nutrition
Major hepatic or renal dysfunction
Participation in other studies within 1 month prior to entry of this study
Allergy to any of the study product ingredients
Investigator concern around willingness/ability of patient or parent/caregiver to comply with protocol requirement
Treatment with Sapropterin dihydrochloride for less than 6 months

Where it is running

University Hospitals Bristol and Weston NHS Foundation Trust — Bristol, United Kingdom

Full record on ClinicalTrials.gov

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