Clinical Trial: Capsule Sponge as a Non‐Endoscopic Monitoring Tool in Eosinophilic Oesophagitis—A Prospective Real–World Multicentre Study

BACKGROUND AND AIMS: Eosinophilic oesophagitis (EoE) is a chronic inflammatory condition requiring repeat endoscopy and biopsy for histological monitoring, which is invasive, resource-intensive and burdensome for patients. The capsule sponge (CS) offers a potential non-invasive alternative. We evaluated the diagnostic accuracy, feasibility and patient acceptability of CS versus endoscopic biopsies for monitoring disease activity in adult patients. METHODS: on endoscopic biopsy histology and CS respectively. Symptom burden was assessed using the Dysphagia Symptom Questionnaire, endoscopic severity using the EoE Endoscopic Reference Score and patient acceptability via structured questionnaire. RESULTS: 136 patients (164 paired episodes) from three secondary care hospitals successfully swallowed CS with sufficient sampling; CS swallowing success rate was 92.7%. Median age was 45 years (IQR 34.8-56); 92/136 (67.6%) were male. CS demonstrated sensitivity 76.3%, specificity 89.5%, PPV 80.4%, NPV 87.0% and overall accuracy 84.8% (Cohen's κ = 0.67). AUC was 0.904 (95% CI 0.856-0.953). Patient acceptability recorded 96.7% found CS acceptable, 78.8% preferred it over endoscopy, and 90.8% would repeat the procedure. No complications occurred. CONCLUSIONS: CS is a safe, feasible, accurate and highly acceptable less-invasive tool for monitoring EoE. Its implementation could improve care pathways, reducing the need for repeated endoscopic biopsies while maintaining diagnostic reliability, with potential to reduce service burden, carbon emissions and improve patient experience. TRIAL REGISTRATION: CoSiE: IRAS number: 314770; ClinicalTrials.gov identifier: NCT06501274; QuBiE: UK Clinical Trial registry identifier: ISRCTN14071734; Trial number: 10083253.