Status:
RECRUITING
Tolerability of an Ancient Grain in Patients With Non-Celiac Wheat Sensitivity
Lead Sponsor:
University of Palermo
Conditions:
Non-celiac Gluten Sensitivity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Patients suffering from wheat-related troubles, in absence of celiac disease or wheat allergy diagnosis, can suffer from non-celiac wheat sensitivity (NCWS). This is characterized by both gastrointest...
Detailed Description
State of the art The association between wheat intake and "wheat-related disorders" (WRDs) has been known for a long time, including pathologies as celiac disease (CD) and wheat allergy (WA). Recently...
Eligibility Criteria
Inclusion
- age \>18 and \<65 years;
- negativity of class A (IgA) and G (IgG) immunoglobulin (Ig) anti-deamidated gliadin (anti-DGP); negativity of IgA and IgG anti-tissue transglutaminase (anti-tTG) and anti-endomysial antibodies (EMA) ;
- absence of intestinal villous atrophy, documented in all patients carrying the DQ2 and/or DQ8 human leukocyte antigen haplotypes (therefore regardless of the negativity of celiac disease-specific serum antibodies);
- absence of wheat allergy (negative prick test and/or serum IgE measurement specific to wheat, gluten and gliadin).
Exclusion
- age \<18 and \>65 years;
- self-exclusion of gluten/wheat from the diet and refusal to reintroduce it, for diagnostic purposes, before entering the study;
- pregnancy;
- alcohol and/or drugs abuse;
- Helicobacter pylori and other bacterial and/or parasitic infections;
- diagnosis of chronic inflammatory intestinal diseases and other organic pathologies affecting the digestive system (for example, serious liver diseases), nervous system diseases, major psychiatric disorders, immunological deficits and impairments that limit physical activity;
- cancer
- patients undergoing chemotherapy and/or radiotherapy.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06191432
Start Date
February 1 2024
End Date
November 30 2026
Last Update
June 22 2025
Active Locations (1)
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1
University Hospital of Palermo
Palermo, Sicily, Italy, 90127