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