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Evaluation of Phe Fluctuation in PKU Pts Treated With PKU GOLIKE Versus Standard Amino Acid Protein Substitute.

NCT05487378 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-02-23

Study results available
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Summary

This is a 2 arm, randomised, controlled, cross-over study in 16 children with PKU. Subjects who are currently taking a Phe free/low Phe protein substitute will be recruited for a 31-day trial.

Patients will be randomised to receive:

1. The study product for 7 days as their last dose of protein substitute for the day (at least one sachet with 15g PE) in an amount equivalent to their usual protein substitute PE; or
2. An amino acid protein substitute for all daily doses for 7 days; followed by a 2-week washout period on their usual protein substitute,

and then 7 days of the other study arm.

During this time, patients/caregivers will be asked to:

* Collect 3 finger prick blood spots on days -1, 0, 6, 7, 20, 21, 27 and 28.
* Collect urine sample, second void of the day on days 0, 7, 21 and 28.
* Complete a questionnaire on sleep quality on day 0, 7, 21 and 28.
* Complete a 24 hour food diary on days -1, 0, 6, 7, 20, 21, 27 and 28.

APR will supply the study product for participants free of charge.

Conditions

  • Phenylketonurias

Interventions

DIETARY_SUPPLEMENT

PKU GOLIKE

AA protein Substitute for the dietary management of PKU, PKU GOLIKE is a food for special medicinal purposes (FSMP) for the dietary management of PKU.

Sponsors & Collaborators

  • APR Applied Pharma Research s.a.

    lead OTHER

Principal Investigators

  • Anita MacDonald, Pr. · Birmingham Children's Hospital, Steelhouse Lane, Birmingham B4 6NH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2024-05-26
Completion
2024-05-26

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05487378 on ClinicalTrials.gov