Non-celiac wheat sensitivity: differential diagnosis, triggers and implications.
Detlef Schuppan, Geethanjali Pickert, Muhammad Ashfaq-Khan...
https://pubmed.ncbi.nlm.nih.gov/26060111Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06191432
Tolerability of an Ancient Grain in Patients With Non-Celiac Wheat Sensitivity A Clinical Study and a Search for Diagnostic Biomarkers
Led by University of Palermo · Updated on 2026-01-12
68
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the tolerability of an ancient diploid wheat, Triticum monococcum (TM), compared to a modern hexaploid wheat, Triticum aestivum (TA), in patients with non-celiac wheat sensitivity (NCWS). NCWS is characterized by gastrointestinal and extra-intestinal symptoms that improve with wheat elimination, but its exact causes and diagnostic markers remain unclear. The study also seeks to identify non-invasive biomarkers and immune cells involved in NCWS to better diagnose and monitor the condition. Participants diagnosed with NCWS following international criteria and a double-blind placebo-controlled wheat challenge will undergo a double-blind crossover trial. They will consume coded flour packets containing either TM or TA for one week each, separated by a one-week washout period. Each dose consists of 80g of flour daily, equivalent to 10g of gluten, which participants will prepare themselves. Symptom severity will be recorded and challenges stopped if reactions occur for at least two consecutive days. Throughout the study, clinical symptoms, quality of life, intestinal permeability, immune responses, and gut microbiota will be assessed at baseline, after each wheat challenge, and post-washout. Blood and fecal samples will be analyzed for inflammatory and immune markers, and a subset will undergo detailed immune cell profiling from biopsy samples. The study duration includes symptom evaluations on days 0, 7, and 21, with ongoing monitoring of immune and microbial changes to understand mechanisms and potential diagnostic tools for NCWS.
CONDITIONS
Brief Title
Tolerability of an Ancient Grain in Patients With Non-Celiac Wheat Sensitivity
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age over 18 and under 65 years
- Negative tests for IgA and IgG anti-deamidated gliadin antibodies
- Negative tests for IgA and IgG anti-tissue transglutaminase and anti-endomysial antibodies
- No intestinal villous atrophy, confirmed in patients with DQ2 and/or DQ8 genetic markers
- No wheat allergy, confirmed by negative skin prick test or specific IgE blood tests
You will not qualify if you...
- Age under 18 or over 65 years
- Self-exclusion of gluten or wheat from diet and refusal to reintroduce it before study
- Pregnancy
- Alcohol or drug abuse
- Infections such as Helicobacter pylori or other bacterial/parasitic infections
- Diagnosis of chronic inflammatory intestinal diseases or serious liver diseases
- Nervous system diseases, major psychiatric disorders, or immunological deficiencies limiting physical activity
- Cancer
- Undergoing chemotherapy or radiotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Double-Blind Wheat Challenge
Duration - Approximately 3 weeks including washout
Participants undergo a crossover dietary challenge with two types of wheat flour, ancient Triticum Monococcum and modern Triticum Aestivum, each administered daily for 1 week. A 1-week washout period without wheat intake occurs between the challenges, allowing symptom resolution. Participants self-report gastrointestinal and extraintestinal symptoms during the challenges.
3 visits (Days 0, 7, and 21; in-person or remote assessments)
Trial Site Locations
Total: 1 location
1
University Hospital of Palermo
Palermo, Sicily, Italy, 90127
Actively Recruiting
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Research Team
P
Pasquale Mansueto, MD
A
Aurelio Seidita, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Published Research Related To This Trial
Duodenal and Rectal Mucosa Inflammation in Patients With Non-celiac Wheat Sensitivity.
Antonio Carroccio, Giulio Giannone, Pasquale Mansueto...
https://pubmed.ncbi.nlm.nih.gov/30138736Influence of low FODMAP and gluten-free diets on disease activity and intestinal microbiota in patients with non-celiac gluten sensitivity.
Walburga Dieterich, Detlef Schuppan, Monic Schink...
https://pubmed.ncbi.nlm.nih.gov/29653862Non-Celiac Gluten Sensitivity: How Its Gut Immune Activation and Potential Dietary Management Differ from Celiac Disease.
Vera Rotondi Aufiero, Alessio Fasano, Giuseppe Mazzarella
https://pubmed.ncbi.nlm.nih.gov/29578652Effect of Triticum turgidum subsp. turanicum wheat on irritable bowel syndrome: a double-blinded randomised dietary intervention trial.
Francesco Sofi, Anne Whittaker, Anna Maria Gori...
https://pubmed.ncbi.nlm.nih.gov/24521561Potential tolerability of ancient grains in non-celiac wheat sensitivity patients: A preliminary evaluation.
Aurelio Seidita, Pasquale Mansueto, Alessandra Giuliano...
https://pubmed.ncbi.nlm.nih.gov/36250065