title: Double-Blind Randomized Clinical Trial: Gluten versus Placebo Rechallenge in Patients with Lymphocytic Enteritis and Suspected Celiac Disease.
abstract: BACKGROUND
  The role of gluten as a trigger of symptoms in non-coeliac gluten sensitivity has been questioned.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  Double-blind randomized clinical trial of gluten vs placebo rechallenge.
  
  
  METHODS
  >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.
  
  
  RESULTS
  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<0.01). The presence of coeliac tissue markers at baseline biopsy on a gluten-free diet allowed classifying 9 out of the 18 (50%) patients as having probable 'coeliac lite' disease.
  
  
  CONCLUSIONS
  This proof-of-concept study indicates that gluten is the trigger of symptoms in a subgroup of patients fulfilling the diagnostic criteria for NCGS. They were characterized by positive celiac genetics, lymphocytic enteritis, and clinical and histological remission after a gluten-free diet.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02472704.
authors.affiliation: Department of Gastroenterology, Hospital Universitari Mutua Terrassa, Terrassa, Barcelona, Spain.|Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.
authors.forename: Mercè
authors.initials: M
authors.lastname: Rosinach
authors.affiliation: Department of Gastroenterology, Hospital Universitari Mutua Terrassa, Terrassa, Barcelona, Spain.|Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Fernández-Bañares
authors.affiliation: Department of Gastroenterology, Hospital Universitari Mutua Terrassa, Terrassa, Barcelona, Spain.|Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.
authors.forename: Anna
authors.initials: A
authors.lastname: Carrasco
authors.affiliation: Department of Gastroenterology, Hospital Universitari Mutua Terrassa, Terrassa, Barcelona, Spain.
authors.forename: Montserrat
authors.initials: M
authors.lastname: Ibarra
authors.affiliation: Department of Gastroenterology, Hospital Universitari Mutua Terrassa, Terrassa, Barcelona, Spain.
authors.forename: Rocío
authors.initials: R
authors.lastname: Temiño
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.|Department of Pathology, Hospital Universitari Mutua Terrassa, Terrassa, Barcelona, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Salas
authors.affiliation: Department of Gastroenterology, Hospital Universitari Mutua Terrassa, Terrassa, Barcelona, Spain.|Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.
authors.forename: Maria
authors.initials: M
authors.lastname: Esteve
mesh_terms: D000328:Adult; D000368:Aged; D002446:Celiac Disease / Q000175:diagnosis*; D055050:Diet, Gluten-Free; D004311:Double-Blind Method; D004751:Enteritis / Q000175:diagnosis*; D005260:Female; D005983:Glutens / Q000737:chemistry* / Q000276:immunology*; D006801:Humans; D008214:Lymphocytes / Q000166:cytology*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D055815:Young Adult
chemical_list: D005983:Glutens