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Response to Different Wheat Genotypes in Not-celiac Wheat Sensitivity

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study completion date: Dec 1, 2024 to Dec 1, 2026
    • Site details revised at 1 of 2 sites
    v9
  2. Notable Primary completion date: Jan 1, 2023 to Jun 1, 2024
    • Study completion date: Aug 1, 2023 to Dec 1, 2024
    v8
  3. Minor Study completion date: Jun 1, 2023 to Aug 1, 2023v7
  4. Notable Primary completion date: Jul 1, 2017 to Jan 1, 2023
    • Study completion date: Jun 1, 2022 to Jun 1, 2023
    v6
  5. Minor Study completion date: Jun 1, 2020 to Jun 1, 2022v5
Show 3 earlier versionsHide 3 earlier versions
  1. Minor Primary completion date: Jul 2017 to Jul 1, 2017
    • Study completion date: Jun 2019 to Jun 1, 2020
    • Start date: Jan 2017 to Jan 1, 2017
    v4
  2. Minor Study completion date: Jun 2018 to Jun 2019v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study completion date: Jan 2018 to Jun 2018
    • Site details revised at 2 of 2 sites
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 sensitivity (NCGS) is a condition where intestinal and extraintestinal symptoms are triggered by gluten ingestion in the absence of celiac disease and wheat allergy. Despite the great interest in NCGS, much remains unknown about the pathogenesis. Some studies seem to suggest that wheat components other than gluten (i.e. amylase/trypsine inhibitors, ATIs) can cause the symptoms, and therefore the term "non-celiac wheat sensitivity" (NCWS) has been proposed instead of NCGS. It is believed that this condition is worldwide increasing, due to the evolution of wheat breeding (i.e. consumption of wheats with high gluten content), and that ancient wheats are better tolerated by NCWS patients than the modern ones. Therefore, the aim of the study is to determine whether the common belief regarding the fact that ancient wheats are better tolerated by NCWS patients than the modern ones is confirmed by scientific data, and to identify the wheat kernel components triggering this pathology. The availability of wheat materials with opposite characteristics, such as the period of development (ancient vs. modern), or the technological properties (cultivars with weak glutens vs. strong gluten), or the presence/absence of specific ATIs polypeptides, will allow to define the role played by these factors. Therefore, the study has two objectives: 1) extraction and testing of total kernel proteins, in order to evaluate the inflammatory response to gluten and non-gluten proteins by peripheral blood mononuclear cells (PBMC) and immunocytes extracted by the rectal mucosa of NCWS patients and healthy control subjects, and 2) clinically testing two wheat genotypes, selected on the basis of the previous in vitro studies, showing the highest and the lowest in vitro inflammatory response, in order to verify their effect in triggering NCWS symptoms.
Trial Details
NCT Number NCT03024775
Lead Sponsor University of Palermo
Conditions
(from sponsor)
Non-celiac Wheat Sensitivity
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov