MedTrace Logo

Acceptability and Tolerance Market Research of a Slow Release, Phenylalanine-free Protein Substitute for the Dietary Management of Phenylketonuria

NCT07802366 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-09-03

No results posted yet for this study

Summary

XPhePiccosMR is a prospective, single-arm, open label, observational study that aims to evaluate the acceptability and tolerability of XPhe Piccos, a slow-release, phenylalanine-free protein substitute in the form of tiny tablets, for use in the dietary management of phenylketonuria (PKU) in children aged three years and older.

Conditions

  • Phenylketonuria (PKU) and Hyperphenylalaninemia
  • Brain Diseases, Metabolic, Inborn
  • Brain Disorder, Metabolic
  • Brain Diseases
  • Central Nervous System Diseases
  • Nervous System Diseases
  • Amino Acid Metabolism, Inborn Errors
  • Metabolism, Inborn Errors
  • Genetic Disease, Inborn
  • Genetic Diseases, Inborn
  • Congenital, Hereditary, and Neonatal Diseases and Abnormalities
  • Metabolic Diseases
  • Nutritional and Metabolic Diseases

Interventions

DIETARY_SUPPLEMENT

Slow release, phenylalanine-free protein substitute tablets

Subjects who currently take a concentrated second stage phenylalanine-free protein substitute will be recruited. Subjects will take the study product for 7 days. Subjects will replace some or all of their usual protein substitute with the new product. The amount of study product prescribed will be calculated to provide the same amount of protein as their usual protein substitute.

Sponsors & Collaborators

  • Birmingham Women's and Children's NHS Foundation Trust

    collaborator OTHER

  • metaX Institut fuer Diatetik GmbH

    lead INDUSTRY

Principal Investigators

  • Anita MacDonald, Professor · Birmingham Women's and Children's NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-05-01
Completion
2027-08-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07802366 on ClinicalTrials.gov