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

Обзор

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.

Вмешательства

• Диагностический тест 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.
• Диагностический тест 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.

Первичные конечные точки

• 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. [Срок оценки: 12 month]

Вторичные конечные точки (4)

• Correlation between urinary GIP concentration and presence of gastrointestinal symptoms [Срок оценки: Month 0 (baseline), Month 6, and Month 12 in the experimental group; Month 12 in the control group.]
• Correlation between urinary GIP test results and pediatrician assessment of gluten intake [Срок оценки: Month 0 (baseline), Month 6, and Month 12 in the experimental group; Month 12 in the control group.]
• Correlation between urinary GIP test results and anti-transglutaminase antibody serology [Срок оценки: Month 0 (baseline), Month 6, and Month 12 in the experimental group; Month 12 in the control group.]
• Assess the satisfaction of patients and parents regarding the integration of the GIP into the therapeutic follow-up strategy for adherence to the RSG [Срок оценки: Month 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval — Nice

Идентификаторы

NCT: NCT07578038 · 25-HPNCL-11 GIped · 2026-A00599-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗