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New PKU drink passes small taste and tolerance test

NCT ID NCT04679467

Disease control Sponsor: Vitaflo International, Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether people with phenylketonuria (PKU) can tolerate and stick with a new protein substitute called PKU Sphere. Thirteen participants gradually increased their intake over up to 16 weeks, then continued for 4 more weeks while researchers tracked their blood levels, gut symptoms, and how much they liked the product. The goal was to see if PKU Sphere is a practical option for managing PKU.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PKU Sphere (a protein substitute made from glycomacropeptide)
What this could lead to
If successful, this could provide a more acceptable and easier-to-use protein substitute for people with PKU, helping them manage their condition better.
What could go wrong
This is a very small study (13 participants) with no control group, so results may not apply to everyone. It only looks at short-term tolerance and adherence, not long-term health outcomes.

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

13 people

The number who actually took part.

Started

Aug 2020

Finished

Jul 2022

Lead sponsor

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

3 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients diagnosed with PKU or hyperphenylalaninemia via new born screening and early treated, requiring \>50% of protein intake from protein substitute. * Aged 3 years and above. * Female patients of childbearing potential must have a negative urine pregnancy test prior to completing the screening procedures. * Willingly given, written, informed consent from the participant, 18 or more years, or from the parent/guardian for participants \< 18 years. * Willingly given, written assent (if appropriate) for those \< 18 years. Exclusion Criteria: * Pregnant, planning pregnancy or breastfeeding. * Intake of sapropterin dihydrochloride (Kuvan), PEG PAL or large neutral amino acids within 30 days prior to screening visit. * Patients currently taking their maximum recommended amount of protein substitute from a GMP based protein substitute. * Patients who are unable/unwilling to replace their current GMP protein substitute (if any) with PKU sphere. * Patients with known soya, milk or fish allergies / intolerance. * Individuals, who in the opinion of the investigator, are unable to comply with the requirements of the protocol. * Any co-morbidity, which in the opinion of the Investigator, would preclude participation in the study. * 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 screening visit.

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Conditions

The condition(s) this trial relates to.

phenylketonuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Phenylketonurias PKU

Contacts and locations

Locations

  • A.O.R.N. Santobono-Pausilipon - Ospedale Santobono

    Naples, Italy

  • Ospedale San Paolo

    Milan, Italy

  • Sant'Orsola-Malpighi Polyclinic (adults)

    Bologna, Italy

  • Sant'Orsola-Malpighi Polyclinic (paediatrics)

    Bologna, Italy

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