New PKU food for babies: will they like it?
NCT ID NCT04898829
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a special medical food called PKU explore in 7 infants with phenylketonuria (PKU) aged 6 months to 3 years. The goal was to see if babies would accept the product, tolerate it well, and maintain healthy phenylalanine levels and growth. The food replaced or supplemented their usual protein substitute over 28 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PKU explore (a special medical food for phenylketonuria)
- What this could lead to
- If successful, this could provide a more acceptable dietary option for managing PKU in infants, potentially improving adherence and growth outcomes.
- What could go wrong
- This is a very small exploratory study with only 7 participants, so results may not apply widely. It focuses on acceptability, not long-term effectiveness or safety.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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7 people
The number who actually took part.
- Started
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May 2022
- Finished
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Oct 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 months to 3 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * A diagnosis of PKU on new-born screening requiring a low protein diet and Phe-free L-amino acid protein substitute. * Aged between 6 months and 3 years (inclusive at screening). * Already taking part of their protein substitute in a spoonable form OR is at the stage in their PKU management when a second stage spoonable protein substitute is recommended to commence. * Well-controlled PKU, evidenced by the latest three routine blood spots being within the acceptable range, in the investigator's opinion. * Able to comply with the study protocol and take the study product, according to the opinion of the investigator. * Willingly given, written, informed consent from parents/guardian. Exclusion Criteria: * Diagnosis of persistent hyperphenylalaninaemia, or mild PKU not requiring dietary intervention with a low protein diet and Phe-free L-amino acid supplements. * Diagnosis of a concurrent condition which may adversely affect developmental progression and feeding ability. * Known milk or fish allergy/intolerance. * Patients who are currently participating in, plan to participate in or have participated in an interventional investigational drug, food or medical device trial within 30 days prior to the screening visit. * Existing significant GI issues which may affect compliance with the study protocol, according to the opinion of the investigator. * Any medical conditions precluding the study intervention, which in the opinion of the investigator may impact on metabolic control during the study period. * Use of additional macro/micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file). * Where applicable, patients NOT covered by Health Insurance System and/or not in compliance with the recommendations of National Law in force.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hôpital Jeanne de Flandre
Lille, Hauts-de-France, 59037, France
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Other studies related to the condition(s) this trial covers.
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