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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-A00599-42 | Other Identifier | Id-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GIP Group | Experimental | 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. |
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| control group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urinary measurement of GIP | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between urinary GIP concentration and presence of gastrointestinal symptoms | Assessment of the correlation between urinary glucose-dependent insulinotropic peptide (GIP) results, measured using the iVYCHECK GIP Urine Test (reported as positive or negative), and the presence of gastrointestinal symptoms. Symptoms are defined as the presence of at least one of the following: abdominal pain, diarrhea, constipation, abdominal distension, or weight loss. Symptom presence will be recorded as a binary outcome (yes/no). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aline JOULIE, PHD | Contact | +33.4.92.03.05.20 | joulie.a@chu-nice.fr | |
| Valérie Dr Triolo, MD | Contact | valerie.triolo@hpu.lenval.com |
| Name | Affiliation | Role |
|---|---|---|
| Valérie Dr Triolo, MD | Fondation Lenval Hôpitaux pediatrique Nice chu Lenval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval | Nice | 06200 | France |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Usual follow-up and measurement of urinary GIP. | Diagnostic Test | 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. |
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| 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 | Assessment of the correlation between urinary glucose-dependent insulinotropic peptide (GIP) results, measured using the iVYCHECK GIP Urine Test (reported as positive or negative), and the assessment of gluten intake performed by a pediatrician. Gluten intake will be evaluated using a standardized clinical assessment based on parental interview and dietary review, and recorded as a binary outcome (gluten intake: yes/no). This assessment includes: voluntary consumption of gluten-containing foods, verification of product labels for gluten content, and evaluation of food choices during meals outside the home. | 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 | Assessment of the correlation between urinary glucose-dependent insulinotropic peptide (GIP) results, measured using the iVYCHECK GIP Urine Test (reported as positive or negative), and anti-transglutaminase antibody levels measured in serum using an enzyme-linked immunosorbent assay (ELISA), expressed in international units per milliliter (IU/mL). Serology results will be analyzed both as a continuous variable (IU/mL) and as a categorical variable defined as negative (< 7 IU/mL) or positive (≥ 7 IU/mL), according to standard laboratory thresholds. Serological assessments will be performed according to routine clinical care at Month 0 (baseline), Month 6, and/or Month 12, as prescribed by the treating physician, in both the experimental and control groups. | 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 | Parental/child satisfaction will be assessed using a Likert scale responding to the following question: 'Does urinary GIP measurement during follow-up reassure you about proper adherence to the gluten-free diet?' This question will be asked to patients over 13 years old or to parents if the child is under 13 years old, with 5 possible response levels, from strongly agree to strongly disagree. | Month 12 |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |