Testing an ancient grain for patients with non-celiac wheat sensitivity
Tolerability of an Ancient Grain in Patients With Non-Celiac Wheat Sensitivity. A Clinical Study and a Search for Diagnostic Biomarkers.
This study is testing if an ancient grain called Triticum monococcum is easier for people with non-celiac wheat sensitivity to tolerate compared to regular wheat.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Palermo Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Palermo, Sicily) |
| Trial ID | NCT06191432 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the tolerability of Triticum monococcum, an ancient grain, in patients suffering from non-celiac wheat sensitivity (NCWS). The study aims to determine whether this diploid wheat species has a lower immunogenic potential compared to common wheat varieties, potentially offering a new dietary option for those affected by NCWS. Participants will be administered flour from both Triticum monococcum and Triticum aestivum to assess their reactions. The trial seeks to provide insights into the management of symptoms associated with wheat-related disorders.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 who have been diagnosed with non-celiac wheat sensitivity and do not have celiac disease or wheat allergy.
Not a fit: Patients who are under 18 or over 65 years old, or those with celiac disease or wheat allergy, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary alternative for patients with non-celiac wheat sensitivity, improving their quality of life.
How similar studies have performed: While there is limited research on the use of ancient grains for non-celiac wheat sensitivity, preliminary evidence suggests that similar approaches may have potential benefits.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Palermo, Sicily
- University Hospital of Palermo — Palermo, Sicily, Italy (Recruiting)
Study contacts
- Study coordinator: Pasquale Mansueto, MD
- Email: pasquale.mansueto@unipa.it
- Phone: 00390916554815
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.