Investigating how different types of wheat affect non-celiac wheat sensitivity
Clinical Response and Cytokines Production After Challenge With Different Wheat Genotypes in Patients With Not-celiac Wheat Sensitivity.
This study is testing whether people with non-celiac wheat sensitivity feel better when eating ancient types of wheat compared to modern varieties.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Palermo Academic / other |
| Locations | 2 sites (Sciacca, Agrigento and 1 other locations) |
| Trial ID | NCT03024775 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the effects of ancient versus modern wheat genotypes on patients with non-celiac wheat sensitivity (NCWS). It will assess whether ancient wheats are better tolerated than modern varieties by analyzing the symptoms triggered by different wheat components, including amylase/trypsin inhibitors (ATIs). Participants will undergo a double-blind, placebo-controlled challenge to evaluate their reactions to various wheat types. The study seeks to provide scientific data to support or refute common beliefs about wheat tolerance in NCWS patients.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with non-celiac wheat sensitivity who have negative tests for celiac disease and wheat allergy.
Not a fit: Patients under 18 years old or those with positive tests for celiac disease or wheat allergy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better dietary recommendations for individuals suffering from non-celiac wheat sensitivity.
How similar studies have performed: While there is ongoing interest in the effects of different wheat types on sensitivity, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sciacca, Agrigento and 1 other locations
- Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca — Sciacca, Agrigento, Italy (Recruiting)
- Department of Internal Medicine, University Hospital of Palermo — Palermo, Palermo, Italy (Recruiting)
Study contacts
- Study coordinator: Antonio Carroccio, PhD
- Email: acarroccio@hotmail.com
- Phone: +390916552884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.