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Search / Trial NCT04077840

Autoimmune Diseases and Serum Autoantibodies in NCWS and IBS Patients

Launched by UNIVERSITY OF PALERMO · Aug 31, 2019

Trial Information

Current as of June 22, 2025

Completed

Keywords

ClinConnect 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). This is very often a self-reported condition, since patients refer to intestinal (mainly irritable bowel syndrome (IBS)-like) and/or extra-intestinal symptoms (i.e. fatigue, headache) caused by gluten or wheat ingestion, even though they do not have celiac disease (CD) or wheat allergy (WA). Given the lack of a diagnostic biomarker, NCGS/NCWS mostly remains a diagnosis of exclusion, especially respect to CD and WA, so a co...

Gender

ALL

Eligibility criteria

  • 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.

About University Of Palermo

The University of Palermo, a distinguished institution located in Italy, is dedicated to advancing medical research and education through innovative clinical trials. Renowned for its commitment to scientific excellence, the university leverages its multidisciplinary expertise and state-of-the-art facilities to conduct research that addresses critical healthcare challenges. By fostering collaborations with leading researchers and healthcare professionals, the University of Palermo aims to translate scientific findings into effective therapies, ultimately contributing to improved patient outcomes and public health advancements.

Locations

Sciacca, Agrigento, Italy

Palermo, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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