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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Adherence to the recommended amount of study product
Timeframe: Days 1 - 28
Product palatability rated on a Likert scale by the patient after 28 days
Timeframe: Day 28
Gastrointestinal tolerance daily diary as reported by the patient
Timeframe: Days 1 - 28
Change in Phe levels
Timeframe: Previous three routine results prior to Visit 1, Visit 1 (Day 0), Week 1, Week 2, Week 3, Week 4 and Visit 2 (Day 28)