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Bio-markers of Not-celiac Wheat Sensitivity

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Study completion date: Dec 1, 2024 to Dec 1, 2026
    • Site details revised at 1 of 2 sites
    v19
  2. Minor Study completion date: Dec 1, 2023 to Dec 1, 2024v18
  3. Minor Study completion date: Jan 1, 2023 to Dec 1, 2023v17
  4. Minor Study completion date: Jan 1, 2022 to Jan 1, 2023v16
  5. Minor Re-verified, no change to tracked fieldsv15
Show 13 earlier versionsHide 13 earlier versions
  1. Minor Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 2 words
    v14
  2. Notable Enrollment target: 40 to 100v13 Show 4 more changesShow less
    • Trial status: Completed to Recruiting
    • Primary completion date: Dec 1, 2016 to Jan 1, 2016
    • Study completion date: Jun 1, 2019 to Jan 1, 2022
    • Site details revised at 2 of 2 sites
  3. Minor Trial status: Recruiting to Completedv12 Show 4 more changesShow less
    • Primary completion date: Dec 2016 to Dec 1, 2016
    • Study completion date changed from estimate of Jun 2019 to Jun 1, 2019
    • Start date: Jan 2012 to Jan 1, 2012
    • Site details revised at 2 of 2 sites
  4. Minor Study completion date: Jun 2018 to Jun 2019v11
  5. Minor Study completion date: Jun 2017 to Jun 2018
    • Site details revised at 1 of 2 sites
    v10
  6. Notable Phase: Phase 3 to Not applicable
    • Study completion date: Feb 2017 to Jun 2017
    v9
  7. Minor Primary completion date: Oct 2016 to Dec 2016
    • Study completion date: Dec 2016 to Feb 2017
    v8
  8. Minor 3 versions Re-verified since Nov 30, 2015, no change to tracked fieldsv5-v7
  9. Notable Primary completion date: Oct 2014 to Oct 2016
    • Study completion date: Dec 2014 to Dec 2016
    v4
  10. Notable Primary completion date: Oct 2013 to Oct 2014
    • Study completion date: Dec 2013 to Dec 2014
    v3
  11. Minor Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The aim of the investigators' study is to evaluate biochemical, immunological and histological characteristics of patients affected with the so-called "gluten (or wheat) sensitivity" who suffers from irritable bowel syndrome (IBS)-like symptoms. As it is not known what component of the cereals causes the symptoms in so called "gluten-sensitive" patients, the investigators prefer to speak of "not-celiac wheat sensitivity" (NCWS). NCWS patients may be defined as ones, neither celiac or allergic to wheat, who develop symptoms following wheat consumption, that improved on wheat/gluten free diet (GFD). For our research, we will select adult patients, both genders, affected with suspected NCWS (i.e. with symptoms/signs which disappeared on GFD and worsen on a gluten containing diet, testing negative for celiac disease \[anti-tissue transglutaminase antibodies, anti-tTG, and anti-endomysium antibodies, EMA, and with biopsy Marsh 0-1\] and wheat allergy \[serum specific IgE for wheat\]). The patients will be recruited at the Department of Internal Medicine, 'Giovanni Paolo II' Hospital of Sciacca (Agrigento), and of Internal Medicine of the University of Palermo, from January 2012 to October 2013, for IBS-like symptoms. At the time of the recruitment, the patients will be on GFD by at least one month and must be asymptomatic. A more restricted elimination diet (with the exclusion of cow's milk, egg and other foods) could be prescribed in patients who are suspected to suffer from multiple food hypersensitivity. The patients will be randomized to undergo a double-blind placebo-controlled study, assuming wheat flour or placebo, administered daily for 15 days. Before and after the challenge, the investigators will evaluate gastrointestinal (Gastrointestinal Symptom Rating Scale, GSRS) and the investigators will collect blood and fecal sampling and biopsies from endoscopic evaluation (both esophagogastroduodenoscopy and rectoscopy, with multiple biopsies), for the identification of possible markers (serological, biochemical, immunological, histological features, expression of cytokines and other constitutive mucosal proteins from peripheral blood mononuclear cells, mucosal lymphocytes and fecal biomarkers) that may be of help to diagnose the condition of NCWS and to understand its pathogenesis.
Trial Details
NCT Number NCT01762579
Lead Sponsor University of Palermo
Conditions
(from sponsor)
Not-celiac Wheat Sensitivity
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov