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

NCT07578038 | Not Yet Recruiting

• 2 other identifiers: 25-HPNCL-11 GIped2026-A00599-42
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coeliac Disease

Keywords

pediatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Correlation between urinary GIP concentration and presence of gastrointestinal symptoms

  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

  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

  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

  Month 12

Study Arms (2)

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.

Diagnostic Test: Urinary measurement of GIP

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.

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

Interventions

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.

Also known as: at M0, at M6, at M12.

GIP Group

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.

control group

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval

Nice, 06200, France

Location

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Valérie Dr Triolo, MD

  Fondation Lenval Hôpitaux pediatrique Nice chu Lenval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical trial manager

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

FR (1)