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Status:

COMPLETED

Autoimmune Diseases and Serum Autoantibodies in NCWS and IBS Patients

Lead Sponsor:

University of Palermo

Conditions:

Non-celiac Gluten Sensitivity

Non-celiac Wheat Sensitivity

Eligibility:

All Genders

18-65 years

Brief Summary

In recent years, a new gluten- or wheat-related disease has emerged, a condition labelled "non-celiac gluten sensitivity" (NCGS) or "non-celiac wheat sensitivity" (NCWS). Given the lack of a diagnosti...

Detailed Description

In recent years, a new gluten- or wheat-related disease has emerged, a condition labelled "non-celiac gluten sensitivity" (NCGS) or "non-celiac wheat sensitivity" (NCWS). This is very often a self-rep...

Eligibility Criteria

Inclusion

  • NCWS
  • Inclusion criteria:
  • resolution of symptoms on a standard elimination diet, without wheat, cow's milk, yeast, and other food(s) causing self-reported symptoms
  • symptom reappearance on a DBPC wheat challenge. As in previous studies, a DBPC cow's milk protein challenge and other open food challenges were also performed
  • age above 18 years and \<65 years
  • follow-up duration longer than 12 months after the initial diagnosis
  • at least two outpatient visits during the follow-up period.
  • Exclusion criteria:
  • positive serum assays for celiac disease (i.e. anti-tissue transglutaminase (anti-tTG) IgA and anti-deamidated gliadin peptides (anti-DGP) IgG antibodies)
  • presence of intestinal villous atrophy, documented in all the patients carrying the DQ2 and/or the DQ8 HLA haplotypes
  • positive IgE-mediated immune-allergy tests to wheat (skin prick tests and/or specific serum IgE detection).
  • IBS IBS diagnosis had been made in accordance with the Rome IV criteria and none of these patients improved on an elimination diet without wheat, cow's milk, egg, tomato or chocolate.

Exclusion

    Key Trial Info

    Start Date :

    January 1 2016

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    October 30 2018

    Estimated Enrollment :

    58 Patients enrolled

    Trial Details

    Trial ID

    NCT04077840

    Start Date

    January 1 2016

    End Date

    October 30 2018

    Last Update

    April 20 2020

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca

    Sciacca, Agrigento, Italy, 92019

    2

    Department of Internal Medicine, University Hospital of Palermo

    Palermo, Italy, 90129