Colon to Rectum
Gut. 2022;71(8):1567–76
Prospective, double-blind diagnostic multicenter study of confocal laser endomicroscopy for wheat sensitivity in patients with irritable bowel syndrome
Objective: A 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 celiac disease. However, a diagnostic test for wheat sensitivity (WS) is missing. The present study evaluated the diagnostic accuracy (sensitivity and specificity) of confocal laser endomicroscopy (CLE) for the identification of WS as primary outcome.
Design: In this prospective, double-blind diagnostic study 147 non-celiac 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.
Results: Of 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% confidence interval [CI]: 38.7–63.9%). A total of 38 of 56 patients without WS were correctly identified by CLE (specificity 67.9%, 97.5% CI: 52.9–79.9%). At 6 months follow-up, CLE correctly identified 49 of 59 food-sensitive patients (sensitivity 83.1%, 97.5% CI: 69.9–91.3%) but specificity was only 32% (97.5% CI: 15.7–54.3%).
Conclusion: In light of the high proportion of patients with irritable bowel syndrome responding to gluten-free diet, the diagnostic accuracy of confocal laser endomicroscopy is too low to recommend widespread use of this invasive procedure.