Double-Blind Randomized Clinical Trial: Gluten versus Placebo Rechallenge in Patients with Lymphocytic Enteritis and Suspected Celiac Disease

The role of gluten as a trigger of symptoms in non-coeliac gluten sensitivity has been questioned. To demonstrate that gluten is the trigger of symptoms in a subgroup of patients fulfilling the diagnostic criteria for non-coeliac gluten sensitivity (NCGS), which presented with lymphocytic enteritis,...

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Bibliographic Details
Published in:PloS one 2016-07, Vol.11 (7), p.e0157879-e0157879
Main Authors: Rosinach, Mercè, Fernández-Bañares, Fernando, Carrasco, Anna, Ibarra, Montserrat, Temiño, Rocío, Salas, Antonio, Esteve, Maria
Format: Article
Language:English
Subjects:
Adult
Aged
Autoimmune diseases
Biology and Life Sciences
Biopsy
Carbohydrates
Care and treatment
Celiac disease
Celiac Disease - diagnosis
Clinical trials
Criteria
Development and progression
Diagnostic systems
Diet
Diet, Gluten-Free
Double-Blind Method
Double-blind studies
Enteritis
Enteritis - diagnosis
Female
Gastroenterology
Genetics
Gluten
Glutens - chemistry
Glutens - immunology
Helicobacter pylori
Histocompatibility antigen HLA
Humans
Lymphocytes - cytology
Male
Medical diagnosis
Medicine and Health Sciences
Middle Aged
Patients
Physiological aspects
Quality of Life
Remission
Sensitivity
Serology
Small intestine
Subgroups
Young Adult
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Summary:The role of gluten as a trigger of symptoms in non-coeliac gluten sensitivity has been questioned. To demonstrate that gluten is the trigger of symptoms in a subgroup of patients fulfilling the diagnostic criteria for non-coeliac gluten sensitivity (NCGS), which presented with lymphocytic enteritis, positive celiac genetics and negative celiac serology. Double-blind randomized clinical trial of gluten vs placebo rechallenge. >18 years of age, HLA-DQ2/8+, negative coeliac serology and gluten-dependent lymphocytic enteritis, and GI symptoms, with clinical and histological remission at inclusion. Eighteen patients were randomised: 11 gluten (20 g/day) and 7 placebo. Clinical symptoms, quality of life (GIQLI), and presence of gamma/delta+ cells and transglutaminase deposits were evaluated. 91% of patients had clinical relapse during gluten challenge versus 28.5% after placebo (p = 0.01). Clinical scores and GIQLI worsened after gluten but not after placebo (p
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0157879