Evaluating biomarkers in patients with not-celiac wheat sensitivity
Official title: Not-celiac Wheat Sensitivity (NCWS) in Patients With Irritable Bowel Syndrome. Randomized Double-Blind Placebo-Controlled Trial (Wheat vs Placebo) for Bio-markers Identification of NCWS and Understanding Its Pathogenetic Mechanisms.
Run by University of Palermo · NCT01762579 · Data updated 2026-11-12
This study is trying to understand how the body reacts to wheat in adults with symptoms that get better on a gluten-free diet and worse when they eat gluten, to help clarify not-celiac wheat sensitivity.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Palermo Academic / other |
| Locations | 2 sites (Sciacca, Agrigento and 1 other locations) |
| Status | Recruiting |
| Started | January 1, 2012 |
| Main results expected | January 1, 2016 |
| Study ends | December 1, 2026 |
| Registry record updated | June 22, 2025 |
| Trial ID | NCT01762579 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-65 with IBS-like symptoms that improve on a gluten-free diet and worsen on a gluten-containing diet.
✕Probably not a fit
Patients diagnosed with celiac disease, wheat allergy, or other significant gastrointestinal conditions will not benefit from this study.
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 assess the biochemical, immunological, and histological characteristics of patients experiencing symptoms related to not-celiac wheat sensitivity (NCWS). Participants will include adults aged 18-65 who have IBS-like symptoms that improve on a gluten-free diet and worsen with gluten consumption. The study will involve testing for celiac disease and wheat allergy to ensure accurate diagnosis. By understanding the immune response to wheat, the researchers hope to clarify the nature of NCWS and its impact on health.
Why it matters
Potential benefit: If successful, this study could lead to better diagnosis and management of not-celiac wheat sensitivity, improving quality of life for affected patients.
How similar studies have gone: While the concept of not-celiac wheat sensitivity is gaining attention, this specific approach to understanding its biomarkers is relatively novel and has not been extensively tested in previous studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients, both genders, with age between 18-65 years, with IBS-like symptoms, that improved on a gluten free diet and worsen on a gluten containing diet * Patients testing negative for celiac disease ( anti-tTG and EMA negative, and with biopsy Marsh 0-1) and wheat allergy (serum specific igE for wheat negative) Exclusion Criteria: * Subjects diagnosed with celiac disease (positive anti-tTG and/or EMA, and positive histology, with Marsh 2 or above); * Subjects diagnosed with wheat allergy (positive serum specific IgE for wheat) * Subjects with Type 1 Diabetes * Subjects with Inflammatory Bowel Diseases (Crohn's disease or ulcerative colitis) * Subjects with Helicobacter pylori infection and other gastrointestinal infection * Pregnancy
Where it's running
-
Internal Medicine, "Giovanni Paolo II" Hospital
Sciacca, Agrigento, Italy Recruiting -
Internal Medicine, University Hospital
Palermo, Palermo, Italy Recruiting
Study contacts
- Principal investigator: Antonio Carroccio, PHD, MD — Internal Medicine, 'Giovanni Paolo II' Hospital of Sciacca (Agrigento) and University of Palermo, Palermo, Italy
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.