Identification of Gluten Sensitivity in Irritable Bowel Syndrome — IBS-NCGS  

Irritable Bowel Syndrome Clinical Trial

Official title: Double Blind Randomized Clinical Trial in Subjects With Irritable Bowel Syndrome for the Identification of Gluten Sensitivity

Status Completed

Clinical Trial Summary

The aim of our study will be to establish in how many subjects with gastrointestinal symptoms and previous diagnosis of irritable bowel syndrome (IBS), the clinical picture is attributable to non celiac gluten sensitivity (NCGS) or fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) intolerance. For this purpose, all subjects with IBS will take a low FODMAPs diet, which implies the absence of cereals and consequently of gluten, and those presenting symptom improvement during this dietary treatment, will be exposed to a double-blind gluten or placebo challenge, to make a diagnosis of NCGS.

Clinical Trial Description

Study design:

For this study, patients with diagnosis of IBS performed by Rome IV criteria and followed as outpatients at the Clinical Nutrition Clinic of "Petrucciani" Nursing Home of Lecce (LE), Italy, will be enrolled.

At baseline, the enrolled subjects will follow a balanced normal-caloric low-FODMAP and gluten-free diet for a period of 4 weeks. At the end of the 4 weeks patients who did not experience an improvement in symptoms will be considered "non-responders" and discontinue the clinical trial. Only those subjects who had showed a significant improvement in symptoms, will be enrolled for the phase 2 of the study that includes a challenge with gluten or with placebo, as described by the Salerno criteria. ;

Related Conditions & MeSH terms

• Hypersensitivity
• Irritable Bowel Syndrome
• Non-celiac Gluten Sensitivity
• Syndrome

• NCT number: NCT04017585
• Study type: Interventional
• Source: University of Bari
• Status: Completed
• Phase: N/A
• Start date: April 8, 2019
• Completion date: October 30, 2019