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

4. maj 2026 opdateret af: Aline JOULIE, Fondation Lenval
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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Frankrig
      • Nice, Frankrig, 06200
        • Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Diagnostisk 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.
Andre navne:
  • at M0
  • at M6
  • at M12.
Aktiv komparator: 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.
Diagnostisk 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 12 month

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation between urinary GIP concentration and presence of gastrointestinal symptoms
Tidsramme: Month 0 (baseline), Month 6, and Month 12 in the experimental group; Month 12 in the control group.
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
Tidsramme: Month 0 (baseline), Month 6, and Month 12 in the experimental group; Month 12 in the control group.

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
Tidsramme: Month 0 (baseline), Month 6, and Month 12 in the experimental group; Month 12 in the control group.

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
Tidsramme: Month 12
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fondation Lenval

Efterforskere

  • Ledende efterforsker: Valérie Dr Triolo, MD, Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2029

Studieafslutning (Anslået)

1. juni 2029

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

11. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25-HPNCL-11 GIped
  • 2026-A00599-42 (Anden identifikator: Id-RCB)

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