NCT04077840

Autoimmune Diseases and Serum Autoantibodies in NCWS and IBS Patients

Completed Last updated 20 April 2020

What this trial tests

trial in Non-celiac Gluten Sensitivity in 58 participants. Completed in 30 October 2018.

Timeline

1 January 2016

Primary endpoint
1 January 2017

30 October 2018

Quick facts

Lead sponsor	University of Palermo
Status	Completed
Study type	OBSERVATIONAL
Enrollment	58
Start date	1 January 2016
Primary completion	1 January 2017
Estimated completion	30 October 2018
Sites	2 locations across Italy

Conditions studied

• Non-celiac Gluten Sensitivity — all drugs for Non-celiac Gluten Sensitivity →
• Non-celiac Wheat Sensitivity — all drugs for Non-celiac Wheat Sensitivity →

Sponsor

University of Palermo

Who can join

Adults 18 to 65, any sex, with Non-celiac Gluten Sensitivity or Non-celiac Wheat Sensitivity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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). 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.