Market Research - Acceptability Study for a New PKU Protein Substitute

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

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-04

Study Completion Date

2019-05-19

Brief Summary

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The aim of this study is to demonstrate that a new protein substitute is acceptable and well tolerated in children with PKU.

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Detailed Description

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Conditions

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PKU Phenylketonurias Inborn Errors of Metabolism Metabolic Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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PKU GMPOWER

(casein) glycomacropeptide protein substitute for the dietary management of PKU from the age of 3 years

Group Type EXPERIMENTAL

GMPOWER

Intervention Type DIETARY_SUPPLEMENT

(casein) glycomacropeptide protein substitute for the dietary management of PKU from the age of 3 years

Interventions

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GMPOWER

(casein) glycomacropeptide protein substitute for the dietary management of PKU from the age of 3 years

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of PKU or PKU variant requiring a protein substitute.
* Subjects who were already taking a phenylalanine-free/low phenylalanine protein substitute and were willing to try the study product for 7 days.
* Patients aged 3 years of age to adulthood.
* Written informed consent obtained from participant or parental caregiver (as appropriate).

Exclusion Criteria

* Presence of serious concurrent illness
* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
* Any patients having taken antibiotics over the previous 2 weeks leading up to the study.
* Patients less than 3 years of age.

Minimum Eligible Age

3 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No