An interventional study of Urinary measurement of GIP and Usual follow-up and measurement of urinary GIP. in Coeliac Disease, sponsored by Fondation Lenval. Not yet recruiting at 1 site in France. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Fondation Lenval · Not applicable, Interventional, and Other
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.
352 studies on the registry are indexed under Celiac Disease; 77 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 214 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →Fondation Lenval is the lead sponsor of 61 studies on the registry; 18 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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.
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.
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.
Time frame: 12 month
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 12
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Jun 2029, 36 months later.
Of 82 non-industry interventional studies with no phase under Celiac Disease, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's planned 36 months is above that.
Counting every sponsor, half of 87 studies reached it within 27 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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