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Autoimmune Diseases and Serum Autoantibodies in NCWS and IBS Patients

NCT04077840 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2020-04-20

No results posted yet for this study

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 diagnostic biomarker, NCGS/NCWS mostly remains a diagnosis of exclusion, especially respect to CD and WA, so a confirmatory test is required. The Salerno experts suggested the double-blind, placebo-controlled (DBPC), cross-over, gluten/wheat challenge as the gold standard test to discriminate true NCGS/NCWS patients. There are conflicting data about the real mechanisms which induce symptoms in NCGS/NCWS patients after wheat ingestion. Some Authors suggested a prevalent role for Fermentable Oligosaccharides-Disaccharides-Monosaccharides and Polyols (FODMAPs), rather than gluten in determining the symptoms. Other studies underlined the activation of mechanisms of both innate and acquired immunity in NCWS patients, after wheat ingestion. In the present study, we included a group of consecutive NCWS patients, diagnosed with DBPC wheat challenge, to evaluate a) the frequency of autoimmune diseases, b) the frequency and pattern of serum ANA and other non-organ-specific and/or organ-specific autoantibodies, and c) the possible correlations between autoimmune diseases and serum autoantibodies presence and other NCWS-related disease characteristics, in comparison with age- and sex- matched healthy blood donors and IBS patients unrelated to NCWS.

Conditions

  • Non-celiac Gluten Sensitivity
  • Non-celiac Wheat Sensitivity

Sponsors & Collaborators

  • University of Palermo

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2017-01-01
Completion
2018-10-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04077840 on ClinicalTrials.gov