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Can tiny tablets replace protein powder for kids with PKU?

NCT ID NCT07802366

Symptom relief Sponsor: metaX Institut fuer Diatetik GmbH Source: ClinicalTrials.gov ↗

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This trial is taking on new participants right now.
Not yet recruiting This study
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Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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The trial has finished. Results may not be published yet.
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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)

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Not a trial. The treatment could once be requested outside a study, but no longer can.
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When the status isn't known

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First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial tests whether XPhe Piccos, a slow-release protein substitute in tiny tablets without phenylalanine, is acceptable and well-tolerated in children aged 3 and older with phenylketonuria (PKU) or hyperphenylalaninemia. Participants replace some or all of their usual protein substitute with the study product for 7 days. Researchers track how much of the product children consume and record any digestive side effects like bloating, nausea, or stomach pain. The goal is to see if this tablet form is a practical dietary 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
Slow-release, phenylalanine-free protein substitute tablets (XPhe Piccos)
What this could lead to
If the tablets are acceptable and well-tolerated, they could offer children with PKU a more convenient way to meet daily protein needs without phenylalanine.
What could go wrong
This is a small, short-term study with only 10 participants over 7 days. It measures acceptability and side effects, not long-term effectiveness, and results may not apply to all children.

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

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

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 to 18 years

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: * Diagnosis of PKU or HPA requiring a phenylalanine-free protein substitute. * Subjects who are already taking a phenylalanine-free protein substitute and are willing to try the study product for 7 days. * Subjects aged 3 years and above. * Written informed assent/consent obtained from subject and/or parental caregiver, depending on subject age. Exclusion Criteria: * Presence of serious concurrent illness. * Lead Dietitian's uncertainty about the willingness or ability of the patient to comply with the protocol requirements * Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study. * Any subject having taken antibiotics over the previous 2 weeks leading up to the study. * Subjects less than 3 years of age

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Conditions

The condition(s) this trial relates to.

Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn brain disorder central nervous system disorder Congenital, Hereditary, and Neonatal Diseases and Abnormalities hereditary disease hyperphenylalaninemia due to tetrahydrobiopterin deficiency inborn disorder of amino acid metabolism inborn errors of metabolism metabolic disease nervous system disorder Nutritional and Metabolic Diseases phenylketonuria

As listed by the trial registrant

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

Amino acid metabolism, inborn errors Brain diseases Brain diseases, metabolic, inborn Brain disorder, metabolic Central nervous system diseases Congenital, hereditary, and neonatal diseases and abnormalities Genetic disease, inborn Genetic diseases, inborn Metabolic diseases Metabolism, inborn errors Nervous system diseases Nutritional and metabolic diseases Phenylketonuria (PKU) and hyperphenylalaninemia

How to take part

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  1. The places running it

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  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Birmingham Children´s Hospital

    Birmingham, England, B4 6NH, United Kingdom

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