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Could a breath test replace blood draws for metabolic disease monitoring?

NCT ID NCT07704606

Knowledge-focused Sponsor: University Children's Hospital, Zurich Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This study measures specific substances (metabolites) in the breath and blood of people with inherited metabolic disorders, those on a special ketogenic diet for epilepsy, and healthy volunteers. The goal is to see if a simple breath test can reliably track these metabolites, potentially replacing painful and frequent blood tests. Researchers will also test a handheld breath sensor for possible home monitoring.

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 lead to a painless, breath-based method for monitoring certain metabolic conditions, reducing the need for frequent blood draws.
What could go wrong
This is an early observational study, not a treatment trial. The breath sensor may not be accurate enough to replace blood tests, and results may not apply to all patients.

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.

Participants

About 100 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

Oct 2037

An estimate. End dates often move.

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.

Who is studied

Patients who are routinely cared for at the study site will be invited to participate. Healthy volunteers will be recruited through communication with healthy family members accompanying patients to hospital visits and the general population through flyers.

Ages

4 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: * Patients aged 4-20 years old with refractory epilepsy on a ketogenic diet, or * Patients aged 4 years old and above with a confirmed diagnosis of urea cycle disorders, organic acidurias, amino acidopathies and fatty acid oxidation defects, or * healthy adults and * informed consent Exclusion Criteria: * Physical findings at screening that would compromise safety of the participant or quality of study data. Examples include presentation of fever, pulmonary complications, presence of disease comorbidities that might interfere with study result and inability to comply with study procedures.

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Conditions

The condition(s) this trial relates to.

amino acid metabolism disease epilepsy inborn errors of metabolism inborn organic aciduria inherited fatty acid metabolism disorder urea cycle disorder

As listed by the trial registrant

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

Epilepsy (treatment refractory) Inborn errors of metabolism

How to take part

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  1. 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 ↗

  2. A doctor treating you

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