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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-18
SponsorFondation Lenval

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Predictable compliance problem in the study

Non-French-speaking patient

Seronegative celiac disease at diagnosis

Chronic kidney disease

Trial design

Treatments tested in this trial

  • Urinary measurement of GIP
  • Usual follow-up and measurement of urinary GIP.

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators