Evaluation of PKU Explore France

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Phenylketonurias

Clinical Trial Details

NCT number	NCT04898829
Study type	Interventional
Source	Vitaflo International, Ltd
Contact
Status	Active, not recruiting
Phase	N/A
Start date	May 18, 2022
Completion date	May 31, 2025

View Details

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