Evaluating the Tolerance, Safety and Acceptability of PKU GMPro, a Whey Protein Derived Feed for the Dietary Management of Phenylketonuria in Children and Adults - a Pilot Trial

Nutricia UK Ltd5 sites in 1 country40 target enrollmentJuly 2016

ConditionsPhenylketonuria

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Phenylketonuria
Sponsor: Nutricia UK Ltd
Enrollment: 40
Locations: 5
Primary Endpoint: Blood Phenylalanine (and other amino acids)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

July 2016

End Date

September 27, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Nutricia UK Ltd

Responsible Party

Sponsor

Eligibility Criteria

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