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PKU patients may have hidden inflammation, study suggests

NCT ID NCT04879277

Knowledge-focused Sponsor: University Hospital, Tours 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 40 adults—some with phenylketonuria (PKU) and some healthy—to see if PKU causes low-level inflammation in the body. Researchers measured inflammatory markers in blood samples. The goal was to better understand how PKU affects overall health, not to test a new treatment.

What this could mean

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

What this could lead to
If successful, this could help understand how phenylketonuria affects the body beyond the brain, possibly pointing to new ways to manage the condition.
What could go wrong
This is a small, completed observational study with only 40 participants. It measures markers of inflammation, not a treatment, so it may not lead directly to any new therapy.

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

40 people

The number who actually took part.

Started

May 2021

Finished

Aug 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 (patient with PKU) * Age \>/= 18 years old * Phenylketonuria diagnosis * Fasting condition * Registered with a social security system * Patient consent Inclusion Criteria (healthy volunteer) * Age \>/= 18 years old * No metabolic condition * Fasting condition * Paired to patient with phenylketonuria already included according to age, sex and BMI class * Registered with a social security system * Volunteer consent Exclusion Criteria, common to healthy volunteer and patient with phenylketonuria * Pregnant and lactating women * Subject to legal protection measures. * Chronic or acute inflammatory disease * Fever on inclusion * Undergoing anti inflammatory treatment * Surgery in the previous months * Diabetes * Included in other therapeutic trial

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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.

Phenylketonuria

Contacts and locations

Locations

  • Clinical investigation center, University Hospital, Tours

    Tours, 37044, France

  • Internal Medicine Service, University Hospital, Tours

    Tours, 37044, France

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