Status:
RECRUITING
GMP Powdered Substitutes in PKU and TYR
Lead Sponsor:
Nutricia UK Ltd
Conditions:
Phenylketonuria
Tyrosinemia
Eligibility:
All Genders
3+ years
Phase:
NA
Brief Summary
Four new GMP-based protein substitutes have been developed to support the dietary management of PKU and TYR. These products are powdered protein substitutes, low in phenylalanine and low in phenylalan...
Eligibility Criteria
Inclusion
- Male or female
- Over 3 years of age
- Patients diagnosed with any phenotype of PKU characterised by hyperphenylalaninaemia or patients diagnosed with tyrosinaemia
- Have been compliant in taking at least one protein substitute, providing at least 15g protein equivalents, for at least 1 month prior to trial commencement
- Have a prescribed daily phenylalanine or phenylalanine and tyrosine allowance for PKU or TYR respectively
- 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 one sachet of GMP Product per day
Exclusion
- 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
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06941532
Start Date
May 20 2025
End Date
December 31 2026
Last Update
December 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham Women and Children's Hospital
Birmingham, United Kingdom