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Interest of Urinary Measurement of Immunogenic Gluten Peptides (GIP) in the Follow-up of Pediatric Celiac Patients.

Key facts

Who runs it
Fondation Lenval
Where
France1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
100 people, planned
Started
Jun 2026
Expected to end
Jun 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Urinary measurement of GIP
  • Usual follow-up and measurement of urinary GIP.
Record updated
11 May 2026

Who can take part

Age
2 years to 18 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Seronegative celiac disease at diagnosis
  • Chronic kidney disease
  • Predictable compliance problem in the study
  • Non-French-speaking patient
  • Patient protected by law, that is, subject to protective measures (judicial safeguard, guardianship, trusteeship, procedures for opening guardianship and trusteeship measures)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 2 and 18 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

The main reason for insufficient control of celiac disease is non-adherence to the gluten-free diet (GFD), whether voluntary or involuntary. In children, involuntary exposures are common (canteens, snacks, restaurants). There are no evidence-based recommendations regarding the best way to follow up with patients and assess adherence to the diet. Monitoring of celiac disease is traditionally based on IgA anti-transglutaminase (IgA anti-tTG) serology, but it reflects a delayed immune response and does not detect occasional exposures. Numerous studies conducted outside of France seem to highlight the usefulness of measuring gluten immunogenic peptides (GIP), compared to the current tools used. Measuring GIP in urine, which is non-invasive and can be performed regularly, could allow for earlier and more objective detection of recent gluten exposure, particularly inadvertent exposure, even before symptoms appear. Furthermore, it could serve as a complementary test for patients who continue to show symptoms or positive serology despite a reported well-followed GFD. In such situations, the use of control esophagogastroduodenoscopy (EGD) with jejunal biopsies could be reconsidered in the event of positive urinary GIP. This is the first study conducted in France on the usefulness of urinary measurement of immunogenic gluten peptides in the follow-up of pediatric celiac patients.

The 2 groups in the trial

  • GIP GroupTreatment being tested

    The test used is the iVYCHECK GIP urine® test, a rapid immunochromatographic test used to detect immunogenic gluten peptides (GIP) in urine. In the experimental group, urinary GIP levels are measured at M0, M6, and M12 with two urine samples collected at home at M6 and two urine samples collected at home at M12 in addition to the sample collected during the consultation.

    Treatment: Urinary measurement of GIP

  • control groupExisting treatment, for comparison

    The test used is the iVYCHECK GIP urine® test, a rapid immunochromatographic test used to detect immunogenic gluten peptides (GIP) in urine. In the control group, standard follow-up at M0, M6. At M12, two urine samples collected at home in addition to the sample collected during the consultation.

    Treatment: Usual follow-up and measurement of urinary GIP.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Fit questions
Built from NCT07578038, who can take part
Record updated
11 May 2026