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PLoS One. 2016 Jul 8;11(7):e0157879. doi: 10.1371/journal.pone.0157879. eCollection 2016.

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

Author information

1
Department of Gastroenterology, Hospital Universitari Mutua Terrassa, Terrassa, Barcelona, Spain.
2
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.
3
Department of Pathology, Hospital Universitari Mutua Terrassa, Terrassa, Barcelona, Spain.

Abstract

BACKGROUND:

The role of gluten as a trigger of symptoms in non-coeliac gluten sensitivity has been questioned.

AIM:

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.

INCLUSION CRITERIA:

>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.

CONCLUSION:

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02472704.

PMID:
27392045
PMCID:
PMC4938236
DOI:
10.1371/journal.pone.0157879
[Indexed for MEDLINE]
Free PMC Article

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