Testing an ancient grain for patients with non-celiac wheat sensitivity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University Hospital of Palermo
  Palermo, Sicily, Italy Recruiting

Study contacts

• Study coordinator: Pasquale Mansueto, MD
• Email: pasquale.mansueto@unipa.it
• Phone: 00390916554815

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.