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Phenylketonuria

GMP Drink for PKU Study

Sponsored by Nutricia UK Ltd

About this trial

Last updated 6 years ago

Study ID

GMP2016

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
3+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 6 years ago

What is this trial about?

This study will evaluate the safety, gastrointestinal (GI) tolerance, acceptability and compliance of a Glycomacropeptide-based protein substitute for patients with Phenylketonuria (PKU).

What are the participation requirements?

Yes

Inclusion Criteria

- Male or female

- Over 3 years of age

- Diagnosed with classical or variant type phenylketonuria

- Have been compliant in taking at least one amino acid-based, Phe-free protein substitute, providing at least 20g protein equivalents, for at least 1 month prior to trial commencement

- Have a prescribed daily Phe allowance

- Written informed consent from patient, or from parent / carer if applicable

No

Exclusion Criteria

- Currently prescribed Sapropterin or similar tetrahydrobiopterin based medication

- 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, including milk protein or soya

- Investigator concern around willingness/ability of patient or parent/carer to comply with protocol requirements