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Bio-markers of Not-celiac Wheat Sensitivity

RecruitingNAAges 18 Years - 65 YearsAllUniversity of Palermo
NCT01762579 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult patients, both genders, with age between 18-65 years, with IBS-like symptoms, that improved on a gluten free diet and worsen on a gluten containing diet * Patients testing negative for celiac disease ( anti-tTG and EMA negative, and with biopsy Marsh 0-1) and wheat allergy (serum specific igE for wheat negative) Exclusion Criteria: * Subjects diagnosed with celiac disease (positive anti-tTG and/or EMA, and positive histology, with Marsh 2 or above); * Subjects diagnosed with wheat allergy (positive serum specific IgE for wheat) * Subjects with Type 1 Diabetes * Subjects with Inflammatory Bowel Diseases (Crohn's disease or ulcerative colitis) * Subjects with Helicobacter pylori infection and other gastrointestinal infection * Pregnancy
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What it tests

  • wheat flour
  • Xylose
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Where

2 sites
Internal Medicine, "Giovanni Paolo II" Hospital
Sciacca, Italy
Internal Medicine, University Hospital
Palermo, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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