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Urinary Gluten Immunogenic Peptides Detection in Non-celiac Gluten/Wheat Sensitivity

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv11
  2. Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    • Site details revised at 1 of 2 sites
    v10
  3. Primary completion date: Dec 1, 2022 to Dec 31, 2024
    • Study completion date: Dec 31, 2023 to Dec 31, 2025
    v9
  4. Re-verified, no change to tracked fieldsv8
  5. Primary completion date: Dec 1, 2021 to Dec 1, 2022
    • Study completion date: Jul 1, 2022 to Dec 31, 2023
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Re-verified, no change to tracked fieldsv6
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    v5
  3. Primary completion date: Dec 1, 2020 to Dec 1, 2021
    • Start date: Jul 1, 2020 to Jan 1, 2021
    • Study completion date: Jul 1, 2021 to Jul 1, 2022
    v4
  4. Start date: Feb 1, 2020 to Jul 1, 2020
    • Primary completion date: Aug 1, 2020 to Dec 1, 2020
    • Study completion date: Feb 1, 2021 to Jul 1, 2021
    v3
  5. Enrollment target: 20 to 40v2 Show 7 more changesShow less
    • Primary endpoints: 2 to 1
    • Primary completion date: Feb 1, 2021 to Aug 1, 2020
    • Study completion date: Feb 1, 2022 to Feb 1, 2021
    • Eligibility criteria shortened, about 24 words
    • Secondary endpoint revised
    • Study description shortened, about 127 words
    • Study title revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Non-celiac gluten/wheat sensitivity (NCGS/NCWS) is a syndrome characterized by both intestinal (irritable bowel syndrome \[IBS\]-like presentation) and extraintestinal symptoms (headache, migraine, "foggy mind", depression, anxiety, fibromyalgia, joint and muscle pain, leg or arm numbness, eczema or skin rash), which occur after the ingestion of gluten/wheat in subjects in which celiac disease (CD) and wheat allergy diagnosis has been previously excluded. NCGS/NCWS symptoms generally occur after the ingestion of gluten/wheat, disappear within a few days of a gluten-free diet (GFD) and quickly reappear when gluten/wheat is reintroduced. A new assay, recently available on the Italian market, allows to ascertain the presence of immunogenic peptides of gluten (Gluten Immunogenic Peptides, GIP) in the urine and stool. The test might allow to ascertain if the NCGS/NCWS patients, on GFD, eat, even accidentally, gluten. Of the 2 available assays, the urinary one allows the patient himself to test the presence of GIP in relation to symptoms/signs appearing and/or social activities (e.g. meal in a restaurant). The aims of the present study are: 1) to test, in patients with NCGS/NCWS on GFD, the adherence to the elimination diet; 2) to evaluate the correlation between the symptoms' reappearance and the presence of GIP in the urine.
Trial Details
NCT Number NCT04219813
Lead Sponsor University of Palermo
Conditions
(from sponsor)		 Non-celiac Gluten/Wheat Sensitivity
Related terms Celiac Disease
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov