Trial reportGut2022
Prospective, double-blind diagnostic multicentre study of confocal laser endomicroscopy for wheat sensitivity in patients with irritable bowel syndrome.
Trial report in Gut, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- European Society for the Study of Coeliac Disease 2025 Updated Guidelines on the Diagnosis and Management of Coeliac Disease in Adults. Part 1: Diagnostic Approach.United European gastroenterology journal · 2025Guideline
- Efficacy and Safety of a Low-FODMAP Diet in Combination with a Gluten-Free Diet for Adult Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis.Digestive diseases and sciences · 2024Pooled it
- Trial
- Immune-based personalized elimination diet for the treatment of irritable bowel syndrome: a double-blind randomized sham-controlled study.Gastroenterology report · 2026Article
- Real-time microscopic visualisation: current applications and challenges of confocal laser endomicroscopy in the diagnosis and treatment of small bowel disorders.Therapeutic advances in gastroenterology · 2026Review
- Confocal Endomicroscopy Intestinal Epithelial Barrier Abnormalities in Individuals Without Documented Gastro-Intestinal Disease.United European gastroenterology journal · 2025Article
- Review
- Leaky Gut Syndrome: Myths and Management.Gastroenterology & hepatology · 2024Article
- Myths and Facts about Food Intolerance: A Narrative Review.Nutrients · 2023Review
- Article
- Irritable bowel syndrome and mental health comorbidity - approach to multidisciplinary management.Nature reviews. Gastroenterology & hepatology · 2023Review
- The Role of Food in the Treatment of Bowel Disorders: Focus on Irritable Bowel Syndrome and Functional Constipation.The American journal of gastroenterology · 2022Article
- Mechanisms Underlying Food-Triggered Symptoms in Disorders of Gut-Brain Interactions.The American journal of gastroenterology · 2022Review
- Review
- Review
Corrections and comments
- Commented on by
Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveA considerable proportion of patients with irritable bowel syndrome (IBS) may be wheat-sensitive and respond to a gluten-free diet (GFD) although they do not have coeliac disease. However, a diagnostic test for wheat sensitivity (WS) is missing. Our study evaluated the diagnostic accuracy (sensitivity and specificity) of confocal laser endomicroscopy (CLE) for the identification of WS as primary outcome.
designIn this prospective, double-blind diagnostic study 147 non-coeliac patients fulfilling the Rome III criteria for IBS were tested by CLE for duodenal changes after wheat (index test), soy, yeast or milk exposure. Patients with IBS responding to 2 months of GFD were classified as having WS (reference test) using response criteria recommended by regulatory bodies for pharmaceutical trials of patients with IBS. After 2 months, CLE results were unblinded and patients were advised to exclude those food components that had led to a positive CLE reaction. The clinical response was assessed at follow-up after 6 and 12 months.
resultsOf 130 patients who completed the study per protocol, 74 (56.9%) responded to GFD and were classified as WS after 2 months, and 38 of these 74 patients were correctly identified by CLE (sensitivity 51.4%; 97.5% CI: 38.7% to 63.9%). A total of 38 of 56 patients without WS were correctly identified by CLE (specificity 67.9%; 97.5% CI: 52.9% to 79.9%). At 6 months follow-up, CLE correctly identified 49 of 59 food-sensitive patients (sensitivity 83.1%; 97.5% CI: 69.9% to 91.3%) but specificity was only 32% (97.5% CI: 15.7% to 54.3%).
conclusionIn light of the high proportion of patients with IBS responding to GFD, the diagnostic accuracy of CLE is too low to recommend widespread use of this invasive procedure. TRAIL REGISTRATION NUMBER: This study was registered as clinical trial in the German Registry for Clinical Studies (DRKS00010123).
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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.