Trial reportPloS one2016
Double-Blind Randomized Clinical Trial: Gluten versus Placebo Rechallenge in Patients with Lymphocytic Enteritis and Suspected Celiac Disease.
Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02472704 (Lymphocytic Enteritis and Suspected Coeliac Disease), which is not on this map. Cited by 15 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Lymphocytic Enteritis and Suspected Coeliac Disease: Double-blind Gluten vs Placebo Rechallenge
Who cites it
15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.
- Effects of a gluten-reduced or gluten-free diet for the primary prevention of cardiovascular disease.The Cochrane database of systematic reviews · 2022Pooled it
- Pooled it
- Trial
- Exposure to Different Amounts of Dietary Gluten in Patients with Non-Celiac Gluten Sensitivity (NCGS): An Exploratory Study.Nutrients · 2019Trial
- Molecular Triggers of Non-celiac Wheat Sensitivity: A Scoping Review and Analysis.The American journal of gastroenterology · 2025Article
- Improving the Diagnosis of Dermatitis Herpetiformis Using the Intraepithelial Lymphogram.Nutrients · 2024Article
- Intestinal and blood lymphograms as new diagnostic tests for celiac disease.Frontiers in immunology · 2022Review
- Article
- Article
- Non-Celiac Gluten Sensitivity: A Review.Medicina (Kaunas, Lithuania) · 2019Review
- A Scoring System for Identifying Patients Likely to Be Diagnosed with Low-Grade Coeliac Enteropathy.Nutrients · 2019Article
- Gluten Vehicle and Placebo for Non-Celiac Gluten Sensitivity Assessment.Medicina (Kaunas, Lithuania) · 2019Review
- Case-finding in primary care for coeliac disease: Accuracy and cost-effectiveness of a rapid point-of-care test.United European gastroenterology journal · 2018Article
- Review
- Re-challenge Studies in Non-celiac Gluten Sensitivity: A Systematic Review and Meta-Analysis.Frontiers in physiology · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe role of gluten as a trigger of symptoms in non-coeliac gluten sensitivity has been questioned.
aimTo 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.
methodsDouble-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.
results91% 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.
conclusionThis 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 registrationClinicalTrials.gov NCT02472704.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.