The Objective is to Confirm the Role of Gluten in Triggering the Digestive and Extradigestive Symptoms of NCGS Clinical Trial
Official title:
GlutN : Randomized, Double-blind, Crossover Clinical Trial to Confirm the Role of Gluten in Non-celiac Gluten Sensitivity
For 25 years, non-celiac gluten sensitivity (NCGS) has been the subject of very prolific and confusing scientific literature. This clinical entity is defined by the appearance of digestive and extradigestive symptoms in the hours/days following the consumption of foods containing gluten, in the absence of celiac disease (CD) and wheat allergy (WA). The physiopathological mechanisms, neither allergic or autoimmune, remain poorly defined and no The main objective of the study was to demonstrate the role of gluten in triggering digestive symptoms and extradigestive products from the NCGS. The secondary objectives were to identify the pathophysiological mechanisms and diagnostic marker(s).usable diagnostic marker in the clinic has not yet been identified.
Twenty patients with possible NCGS on clinical examination and after elimination of CD and AB were included in a study monocentric, randomized, double-blind and crossover design, comparing a gluten-containing diet (RAG) to a gluten-free diet (RSG). The inclusion visit included a specific questioning about digestive and extradigestive symptoms triggered by the consumption of foods with gluten, personal and family history of autoimmune disease, allergy, atopic condition. A dietary consultation made it possible to specify the strict and controlled RSG in FODMAPs (basal diet - RB) to be maintained throughout the 6 weeks of study. After an initial period (PI) of 2 weeks with this RB, patients added for 1 week either foods with gluten (8 g of gluten/d - RAG) or gluten-free foods (RSG) (test periods - PT), the 2 PT being separated by a wash-out period (PWO) of 2 to 3 weeks. Digestive and extradigestive symptoms were assessed by the modified Gastrointestinal Symptom Rating Scale (GSRS) using a 7-point Likert scale (1: absent - 7: very severe), at the end of each week of IP and PWO ( D7 and D14) and every day of each PT. If the symptoms were too severe during PT (i.e. sides of 7), the patient was allowed to stop after a minimum of 72 hours of consumption. For the study of markers of inflammation, immunity, intestinal permeability and metabolomic analyses, blood and urine samples were taken at inclusion and at the end of each PT (or at the end premature). The primary endpoint was the difference in GSRS score at the end of the 2 PTs. Statistical analyzes were carried out using mixed models for a crossover design taking into account subject, diet, period, order and sequence effects and their interactions. ;