Actively Recruiting
Response to Different Wheat Genotypes in Not-celiac Wheat Sensitivity
Led by University of Palermo · Updated on 2025-06-22
50
Participants Needed
2
Research Sites
517 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Response to Different Wheat Genotypes in Not-celiac Wheat Sensitivity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Negative serum anti-tissue transglutaminase and antiendomysium IgA and IgG antibodies
- No intestinal villous atrophy
- Negative IgE-mediated allergy tests to wheat (skin prick tests or serum specific IgE)
- Follow-up longer than 12 months after initial diagnosis
- At least two outpatient visits during follow-up
- Gastrointestinal symptoms resolved on a wheat-free elimination diet
- Symptoms reappear during double-blind placebo-controlled wheat challenge
You will not qualify if you...
- Under 18 years of age
- Positive EmA in duodenal biopsy culture even if villi to crypt ratio is normal
- Self-exclusion of wheat from diet and refusal to reintroduce before study
- Other organic gastrointestinal diseases (e.g., Crohn's disease)
- Current treatment with steroids or antihistamines
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca
Sciacca, Agrigento, Italy, 92019
Actively Recruiting
2
Department of Internal Medicine, University Hospital of Palermo
Palermo, Palermo, Italy, 90129
Actively Recruiting
Research Team
A
Antonio Carroccio, PhD
CONTACT
P
Pasquale Mansueto, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
4
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