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RECRUITINGINTERVENTIONAL

Response to Different Wheat Genotypes in Not-celiac Wheat Sensitivity

Clinical Response and Cytokines Production After Challenge With Different Wheat Genotypes in Patients With Not-celiac Wheat Sensitivity.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 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. Exclusion Criteria: 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.

Treatments Being Tested

DIETARY_SUPPLEMENT

Wheat flour

Wheat flour will be administered three times per day for 15 days.

DIETARY_SUPPLEMENT

Placebo

Placebo (xylose) will be administered three times per day for 15 days.

Locations (2)

Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca
Sciacca, Agrigento, Italy
Department of Internal Medicine, University Hospital of Palermo
Palermo, Palermo, Italy