Study of Not-celiac Wheat Sensitivity in Adults with IBS-like Symptoms Randomized Double-Blind Trial Comparing Wheat Flour and Placebo for Biomarker Identification

What this Trial Is About

Researchers are studying adults aged 18 to 65 with symptoms similar to irritable bowel syndrome IBS who may have not-celiac wheat sensitivity NCWS. This condition causes symptoms after eating wheat but is not celiac disease or wheat allergy. The study aims to identify biological markers and better understand NCWS by comparing patients who improve on a gluten-free diet but worsen when wheat is reintroduced. Participants will be randomly assigned to receive either wheat flour or a placebo xylose three times daily for 15 days in a double-blind setup. Before this challenge, patients will follow a gluten-free diet and may also follow a more restricted elimination diet if multiple food sensitivities are suspected. The study will collect blood, stool, and tissue samples via endoscopic biopsies to analyze immune and biochemical responses. During the study, researchers will monitor gastrointestinal symptoms using the Gastrointestinal Symptom Rating Scale and evaluate changes in biological markers before and after the dietary challenge. The trial includes careful symptom tracking, laboratory tests, and biopsies to help diagnose NCWS and understand its causes. The study is expected to continue until December 2026.

Bio-markers of Not-celiac Wheat Sensitivity