Response to Different Wheat Genotypes in Not-celiac Wheat Sensitivity

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Non-celiac Wheat Sensitivity

In brief

Non-celiac gluten sensitivity (NCGS) is a condition where intestinal and extraintestinal symptoms are triggered by gluten ingestion in the absence of celiac disease and wheat allergy. Despite the great interest in NCGS, much remains unknown about the pathogenesis. Some studies seem to suggest that wheat components other than gluten (i.e. amylase/trypsine inhibitors, ATIs) can cause the symptoms, and therefore the term "non-celiac wheat sensitivity" (NCWS) has been proposed instead of NCGS. It is believed that this condition is worldwide increasing, due to the evolution of wheat breeding (i.e. consumption of wheats with high gluten content), and that ancient wheats are better tolerated by NCWS patients than the modern ones. Therefore, the aim of the study is to determine whether the common belief regarding the fact that ancient wheats are better tolerated by NCWS patients than the modern ones is confirmed by scientific data, and to identify the wheat kernel components triggering this pathology. The availability of wheat materials with opposite characteristics, such as the period of development (ancient vs. modern), or the technological properties (cultivars with weak glutens vs. strong gluten), or the presence/absence of specific ATIs polypeptides, will allow to define the role played by these factors. Therefore, the study has two objectives: 1) extraction and testing of total kernel proteins, in order to evaluate the inflammatory response to gluten and non-gluten proteins by peripheral blood mononuclear cells (PBMC) and immunocytes extracted by the rectal mucosa of NCWS patients and healthy control subjects, and 2) clinically testing two wheat genotypes, selected on the basis of the previous in vitro studies, showing the highest and the lowest in vitro inflammatory response, in order to verify their effect in triggering NCWS symptoms.

Key facts

Study ID: NCT03024775
Run by: University of Palermo
People needed: 50
Starts: 2017-01-01
Expected to finish: 2026-12-01
Last updated by the study team: 2025-06-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All the patients will meet the recently proposed criteria:
negative serum anti-tissue transglutaminase and antiendomysium (EmA) immunoglobulin (Ig)A and IgG antibodies
absence of intestinal villous atrophy
IgE-mediated immunoallergic tests negative to wheat (skin prick tests and/or serum specific IgE detection)
follow-up duration >12 months after the initial diagnosis
at least two outpatient visits during the follow-up period.
Adjunctive criteria adopted in our patients will be:
resolution of the gastrointestinal symptoms on a standard elimination diet, without wheat, cow's milk, egg, tomato, chocolate, or other food(s) causing self-reported symptoms
symptom reappearance on DBPC wheat challenge, performed as described previously. As in previous studies, DBPC cow's milk protein challenge and other "open" food challenges will be also performed.

You may not qualify if…

Exclusion criteria will be:
age <18 years
positive EmA in the culture medium of the duodenal biopsies, even if the villi to crypts ratio in the duodenal mucosa was normal
self-exclusion of wheat from the diet and refusal to reintroduce it before entering the study
other organic gastrointestinal diseases (i.e. careful exclusion of Crohn's disease)
concomitant treatment with steroids and/or antihistamines.

Where it is running

Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca — Sciacca, Agrigento, Italy (enrolling)
Department of Internal Medicine, University Hospital of Palermo — Palermo, Palermo, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.