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Be Part of Research - Trial Details - Evaluation of Phe Fluctuation in PKU Pts Treated With PKU GOLIKE Versus Standard Amino Acid Protein Substitute.
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Evaluation of Phe Fluctuation in PKU Pts Treated With PKU GOLIKE Versus Standard Amino Acid Protein Substitute.

Completed

Open to: ALL

Age: 5.0 - 16.0

Birmingham

Medical Conditions

Phenylketonurias

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jun 2023 May 2024

INTERVENTIONAL

Intervention Type : DIETARY_SUPPLEMENT
Intervention Description : 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.

Intervention Arm Group : 1st AA protein substitute 2nd PKU GOLIKE;1st PKU GOLIKE 2nd AA protein substitute;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Birmingham Children's Hospital Steelhouse Lane
    Birmingham
    B4 6NH


The study is sponsored by APR Applied Pharma Research s.a.



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Read full details for Trial ID: NCT05487378
Last updated 31 July 2024

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