Evaluation of PKU Explore France
- Conditions
- Phenylketonurias
- Registration Number
- NCT04898829
- Lead Sponsor
- Vitaflo International, Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - A diagnosis of PKU on new-born screening requiring a low protein diet and Phe-free<br> L-amino acid protein substitute.<br><br> - Aged between 6 months and 3 years (inclusive at screening).<br><br> - Already taking part of their protein substitute in a spoonable form OR is at the<br> stage in their PKU management when a second stage spoonable protein substitute is<br> recommended to commence.<br><br> - Well-controlled PKU, evidenced by the latest three routine blood spots being within<br> the acceptable range, in the investigator's opinion.<br><br> - Able to comply with the study protocol and take the study product, according to the<br> opinion of the investigator.<br><br> - Willingly given, written, informed consent from parents/guardian.<br><br>Exclusion Criteria:<br><br> - Diagnosis of persistent hyperphenylalaninaemia, or mild PKU not requiring dietary<br> intervention with a low protein diet and Phe-free L-amino acid supplements.<br><br> - Diagnosis of a concurrent condition which may adversely affect developmental<br> progression and feeding ability.<br><br> - Known milk or fish allergy/intolerance.<br><br> - Patients who are currently participating in, plan to participate in or have<br> participated in an interventional investigational drug, food or medical device trial<br> within 30 days prior to the screening visit.<br><br> - Existing significant GI issues which may affect compliance with the study protocol,<br> according to the opinion of the investigator.<br><br> - Any medical conditions precluding the study intervention, which in the opinion of<br> the investigator may impact on metabolic control during the study period.<br><br> - Use of additional macro/micronutrient supplements during the study period, unless<br> clinically indicated and prescribed by the investigator (must be recorded in patient<br> case record file).<br><br> - Where applicable, patients NOT covered by Health Insurance System and/or not in<br> compliance with the recommendations of National Law in force.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adherence to the recommended amount of study product;Product palatability rated on a Likert scale by the patient after 28 days;Gastrointestinal tolerance daily diary as reported by the patient;Change in Phe levels
- Secondary Outcome Measures
Name Time Method Evaluation of growth for a maximum of two years follow up period;Product adherence for a maximum of two years follow up period by measuring the quantity of product intake;Product adherence for a maximum of two years follow up period by measuring the Phe levels