Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347341
Status:
TERMINATED
Last Update Posted:
2024-04-04
First Post:
2024-03-29
Brief Title:
GlutN Randomized Double-blind Crossover Clinical Trial to Confirm the Role of Gluten in Non-celiac Gluten Sensitivity
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
GlutN Randomized Double-blind Crossover Clinical Trial to Confirm the Role of Gluten in Non-celiac Gluten Sensitivity
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
insufficient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GLUTN
Brief Summary:
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 hoursdays 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 markersusable diagnostic marker in the clinic has not yet been identified
Detailed Description:
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 glutend - 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None