NCT04898829

Evaluation of PKU Explore France

An Exploratory Study to Evaluate the Acceptability of PKU Explore, a Food for Special Medical Purposes, for Use in the Dietary Management of Phenylketonuria in Infants From 6 Months to 3 Years of Age With Regard to Product-acceptability, Tolerance, Phe Levels and Growth

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Vitaflo International, Ltd · Industry
• Sex: All
• Age: 6 Months – 3 Years
• Healthy volunteers: Not accepted

Summary

PKU explore France is an exploratory study to evaluate the acceptability of PKU explore, a food for special medical purposes, for use in the dietary management of phenylketonuria in infants from 6 months to 3 years of age, assessing participant adherence, GI tolerance, phe levels, growth and product palatability.

Detailed description

The study product, PKU explore, is a concentrated, spoonable, protein substitute food for special medical purposes, used in the dietary management of PKU. The recommended amount will be determined by a dietitian or clinician and the product used is unflavoured. PKU explore France is an exploratory study to evaluate the gastrointestinal tolerance, palatability, and participant adherence over a four-week period in patients with PKU that follow an appropriate restricted therapeutic diet. This will be followed by a maximum 24-month follow-up period monitoring growth as per routine standard of care. Up to 10 participants will be recruited at a single centre in France. For 28 consecutive days, up to 10 participants, aged 6 months to 3 years inclusive, take their usual restricted therapeutic diet, either replacing their usual second-stage, concentrated protein substitute with PKU explore or commencing PKU explore and gradually reducing their Phe-free formula for infants. Their parent/guardian complete a daily questionnaire on adherence and tolerance, and a final questionnaire on usage and acceptability.

Conditions

• Phenylketonurias

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	PKU explore	For 28 consecutive days, participants will take their usual restricted therapeutic diet, either: \- Replacing their usual second stage concentrated protein substitute with PKU explore OR \- Commencing PKU explore and gradually reducing their Phe-free formula for infants.

Timeline

• Start date: 2022-05-18
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2021-05-24
• Last updated: 2025-11-28

Locations

1 site across 1 country: France