Response to Different Wheat Genotypes in Not-celiac Wheat Sensitivity

Launched by UNIVERSITY OF PALERMO · Jan 16, 2017

Keywords

ClinConnect Summary

This clinical trial is investigating how different types of wheat affect people with non-celiac wheat sensitivity (NCWS), a condition where certain wheat components, not just gluten, can cause digestive and other symptoms. Researchers want to find out if ancient types of wheat are easier for patients to tolerate compared to modern varieties, and they will study specific proteins in wheat that may trigger symptoms. By understanding these differences, the goal is to provide clearer guidance for people experiencing NCWS.

To participate in this study, individuals must be between 18 and 75 years old and have been diagnosed with NCWS based on specific criteria, like having negative tests for celiac disease and wheat allergies. Participants will be closely monitored for their reactions to different wheat types and will undergo tests to see how their bodies respond to the proteins in these wheats. This study aims to give better insights into managing wheat sensitivity and improving dietary choices for those affected.

Gender

ALL

Eligibility criteria

• 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.