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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coeliac Disease
• Intervention / Treatment: Diagnostic test: Urinary measurement of GIP; Diagnostic test: Usual follow-up and measurement of urinary GIP.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aline JOULIE, PHD; Phone Number: +33.4.92.03.05.20; Email: joulie.a@chu-nice.fr
• Study Contact Backup: Name: Valérie Dr Triolo, MD; Email: valerie.triolo@hpu.lenval.com

Study Locations

• France
  • Nice, France, 06200
    • Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval
    • Contact: Valerie Dr Triolo, MD; Phone Number: +33492030520; Email: valerie.triolo@hpu.lenval.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GIP Group; 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.	Diagnostic test: 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.; Other Names: at M0; at M6; at M12.
Active Comparator: control group; 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.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: Fondation Lenval
• Investigators: Principal Investigator: Valérie Dr Triolo, MD, Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: pediatrics
• Additional Relevant MeSH Terms: Metabolic Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Malabsorption Syndromes; Nutritional and Metabolic Diseases; Celiac Disease
• Other Study ID Numbers: 25-HPNCL-11 GIped; 2026-A00599-42 (Other Identifier: Id-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No