Loading clinical trials...

Evaluation of PKU Explore | Clinical Trials | Clareo Health

COMPLETEDNA

Evaluation of PKU Explore

A Study to Evaluate the Acceptability of PKU Explore, a Renovated Phenylalanine Free Second Stage Protein Substitute for Use in the Dietary Management of Phenylketonuria in Infants From 6 Months to 5 Years of Age With Regard to Product Tolerance and Adherence.

NCT03168399•Vitaflo International, Ltd

View on ClinicalTrials.gov

Summary

To evaluate the acceptability, tolerance and effect on metabolic control of PKU Explore, a renovated Phe free protein substitute for the dietary management of PKU in children from 6 months to 5 years.

Detailed Description

This is a prospective, acceptability study to evaluate the gastrointestinal tolerance, palatability and adherence of PKU explore in a four-week period for 15 participants aged between 6 months and 5 years for the dietary management of PKU. The outcome of this assessment will be used in a submission to the regulatory authorities, Advisory Committee on Borderline Substances (ACBS), for PKU Start to become reimbursable on prescription in the UK. The participant's dietitian will advise on an appropriate amount of PKU Explore based on individual requirements. Parents/carers will be asked to substitute their usual Phe-free protein substitute with PKU Explore for one (1) month. The sponsor will supply PKU Explore free of charge. Parents/guardians will be asked to record information about the following: Daily PKU Explore intake Stools Vomiting and Spit-up Feed / Fluid Intake Compliance Phenylalanine Levels (from their routine blood spot testing) Final Evaluation about the presentation of the product, ease of preparation and use.

Eligibility

Age

0 - 5 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•i. A diagnosis of PKU on new-born screening requiring a low protein diet and Phe-free L-amino acid supplements.
•ii. Aged between 6 months and 5 years.
•iii. Already taking a second stage concentrated protein substitute as part of their PKU management OR is at the stage in their PKU management when a second stage concentrated protein substitute is recommended to commence.
•iv. Willingly given, written, informed consent from parent/guardian.
•v. Willingly given, written assent (if appropriate).

Exclusion Criteria

•i. Diagnosis of persistent hyperphenylalaninaemia, or mild PKU not requiring dietary treatment with a low protein diet and Phe-free L-amino acid supplements.
•ii. Diagnosis of a concurrent condition which may adversely affect developmental progression and feeding ability.
•iii. Participation in any other clinical trial/acceptability study.
•iv. Any serious medical precluding the study intervention.
•v. Use of additional macro/micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file).

Locations (3)

NHS Greater Glasgow and Clyde

Glasgow, Lanarkshire, United Kingdom

Birmingham Women's and Children's NHS Foundation Trust

Burringham, West Midlands, United Kingdom

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, West Yorkshire, United Kingdom

Key Dates

Start Date

June 8, 2017

Primary Completion Date

March 15, 2018

Completion Date

March 15, 2018

Last Updated

February 16, 2024

Enrollment

ACTUAL participants

Conditions

PhenylketonuriaInborn Errors of Metabolism

Interventions

PKU Explore

DIETARY_SUPPLEMENT

Institutional Registry of Rare Diseases

NCT06573723

Rare DiseasesAmyloidosis+24 more

View study

RECRUITINGNA

Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria

NCT06560736

Phenylketonurias

View study

RECRUITINGPHASE1/PHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Evaluation of PKU Explore

Inclusion Criteria

Exclusion Criteria

Institutional Registry of Rare Diseases

Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria

AAV Gene Therapy Clinical Study in Adult Classic PKU (PHEdom)

Education & Care in RARE: Efficacy of Targeted Psychoeducational Intervention Among Pediatric Rare Disease Patients

Rapid Drug Desensitization Study in Adults Experiencing Hypersensitivity Reactions to Palynziq

Study to Evaluate the Safety and Efficacy of Pegvaliase in Adolescents (Ages 12-17) With Phenylketonuria