An interventional study of PKU explore in Phenylketonurias, sponsored by Vitaflo International, Ltd. Completed at 1 site in France. Open to participants aged 6 Months to 3 Years. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by Vitaflo International, Ltd (part of Nestlé S.A.) · Not applicable, Interventional, and Supportive care
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.
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.
191 studies on the registry are indexed under Phenylketonurias; 40 are open to participants now.
This study's enrollment of 7 is below the median of 27 across 122 interventional studies indexed under Phenylketonurias.
Browse Phenylketonurias studies →Vitaflo International, Ltd is the lead sponsor of 23 studies on the registry; none are open to participants now.
First submitted after Vitaflo International, Ltd became part of Nestlé S.A..
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PKU Explore will be prescribed by the study dietitian based on the patient's individual requirement.
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.
Adherence to the recommended amount of study product
Quantitative assessments from subject questionnaires that allow evaluation of compliance with the study product (i.e. actual versus prescribed intake), measured in grams consumed per day.
Time frame: Days 1 - 28
Product palatability rated on a Likert scale by the patient after 28 days
Patient assessment of study product's palatability using a Likert scale. At the end of the 28-day acceptability phase, participants/parents/guardians will be required to complete a Product Acceptability Questionnaire to record perceptions about: the appearance, smell, taste, aftertaste, texture, packaging/presentation of the product, also the ease of preparation and administration. These will be on a 5-point Likert scale as Loved it, Liked it, Neither liked nor disliked it, Didn't like it and Really didn't like it.
Time frame: Day 28
Gastrointestinal tolerance daily diary as reported by the patient
Qualitative assessments from subject questionnaires to allow evaluation of any self-reported gastrointestinal symptoms during the study period.
Time frame: Days 1 - 28
Change in Phe levels
Analysis of results from routine dried blood spots. Change in Phe level at diagnosis and at different timepoints measured as µmol/l.
Time frame: 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)
Evaluation of growth for a minimum of two years follow up period
Height/length, weight and head circumference measurements will be combined to complete the growth chart at each visit. All recorded weights, lengths, and head circumferences will be plotted on a Croissance Somatique Des Garçons/Filles De La Naissance A 3 Ans Chart. The units of measurement are height/length in centimeters, weight in kilograms, and head circumference in centimeters.
Time frame: Visit 1 (day 0), Visit 2 (Day 28) and Every 4 months for a max. 24 Months' Followup
Product adherence for a minimum of two years follow up period by measuring the quantity of product intake
Measurement of the quantity of product intake. Quantitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake. Weight of powder prescribed per 24 hours in g (grams) and the number of feeds prescribed per 24 hours (feeds) will be recorded.
Time frame: days 1 - 28
Product adherence for a minimum of two years follow up period by measuring the Phe levels
Measurement of phe levels in µmol/l throughout the evaluation period. The latest Phe level results will be recorded at each visit as µmol/l and compared.
Time frame: Visit 1 (Day 0), Week 1, Week 2, Week 3, Week 4, Visit 2 (Day 28) and every 4 months for a max. 24 Months' Follow-up period
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2022 to primary completion in Oct 2025, 41 months.
Of 33 interventional studies with no phase under Phenylketonurias, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 28. This study's 41 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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