Investigating how different types of wheat affect 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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.