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

Condition(s) studied

Investigational drug(s) / intervention(s)

Urinary measurement of GIP: 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.

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

Study summary

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.

Eligibility

Primary outcome measure(s)

• Compare the 1-year effectiveness of a clinical follow-up strategy based on urinary GIP measurement versus standard care, in patients with celiac disease in the pediatric population. — 12 month
  The effectiveness of care guided by urinary GIP testing, combined with reinforced dietary assessment by a dietitian, will be evaluated at Month 12 using urinary GIP measurements. A positive GIP result is defined as evidence of recent gluten ingestion. The test provides an immediate binary outcome (positive or negative). At each assessment time point, patients will be classified as GIP-positive if at least one of the three urine tests performed is positive. At baseline (M0), where only a single test is conducted, GIP status will be determined based on that result alone.

Trial sites (1)

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