Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT03024775

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here