GMP Drink for PKU Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-09-27

Brief Summary

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

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Detailed Description

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Conditions

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Phenylketonuria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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GMP

Single arm designed, 3 day baseline, 28day on GMP

Group Type EXPERIMENTAL

Glycomacropeptide-based protein substitute

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Glycomacropeptide-based protein substitute

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

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

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No