Response to Different Wheat Genotypes in Not-celiac Wheat Sensitivity
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 othe
| Condition(s) | Non-celiac Wheat Sensitivity |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | 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, D |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | University of Palermo |
| Locations | Sciacca, Agrigento, Italy; Palermo, Palermo, Italy |
| Start date | 2017-01-01 |
| NCT ID | NCT03024775 |
| Official listing | https://clinicaltrials.gov/study/NCT03024775 |