Evaluating biomarkers in patients with not-celiac wheat sensitivity
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.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Palermo Academic / other |
| Locations | 2 sites (Sciacca, Agrigento and 1 other locations) |
| Trial ID | NCT01762579 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients diagnosed with celiac disease, wheat allergy, or other significant gastrointestinal conditions will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Sciacca, Agrigento and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.