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Pee test could catch hidden gluten in kids with celiac disease

NCT ID NCT07578038

Diagnosis Sponsor: Fondation Lenval 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a urine test that detects gluten peptides in children with celiac disease who are on a gluten-free diet. The goal is to see if this test helps doctors and families identify accidental gluten exposure better than standard blood tests. One hundred children aged 2 to 18 will provide urine samples at home and during clinic visits over a year. If it works, the test could reduce the need for invasive procedures like endoscopy.

What this could mean

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

Active substance
urine test for gluten peptides (iVYCHECK GIP urine test)
What this could lead to
If successful, this urine test could help doctors and families quickly spot accidental gluten intake in children with celiac disease, potentially reducing the need for invasive biopsies.
What could go wrong
This is an early study in France with only 100 children, and the test may not be accurate enough to replace current monitoring methods. It also only detects recent gluten exposure, not long-term diet control.

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 100 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

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.

Ages

2 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: * Children aged 2 to 18 years. * Confirmed diagnosis of celiac disease according to ESPGHAN criteria. * Gluten-free diet followed for ≥ 6 months. * Signed informed consent by one of the 2 parents or the legal guardian and oral or written assent from the child. * Affiliation to a social security scheme Exclusion Criteria: * Predictable compliance problem in the study * Non-French-speaking patient * Seronegative celiac disease at diagnosis * Chronic kidney disease * Patient protected by law, that is, subject to protective measures (judicial safeguard, guardianship, trusteeship, procedures for opening guardianship and trusteeship measures)

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Conditions

The condition(s) this trial relates to.

celiac disease

As listed by the trial registrant

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

Coeliac disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval

    Nice, 06200, France

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