Modified Helicobacter test using a new test meal and a (13)C-urea breath test in Helicobacter pylori positive and negative dyspepsia patients on proton pump inhibitors

AIM: To determine the sensitivity and specificity of the (13)C-urea breath test (UBT) in patients taking proton pump inhibitors (PPIs), using a new test meal Refex. METHODS: One hundred and fourteen consecutive patients with dyspepsia, 53 Helicobacter pylori (H. pylori) positive, 49 H. pylori negative, were included in the study. The patients were then given esomeprazole 40 mg for 29 consecutive days, and the (13)C-UBT with the new test meal was performed the next morning. RESULTS: The sensitivity of the (13)C-UBT with a cut off 2.5‰ was 92.45% (95%CI: 81.79%-97.91%) by per-protocol (PP) analysis and 78.13% (95%CI: 66.03%-87.49%) by intention-to-treat (ITT) analysis. The specificity of the (13)C-UBT test was 96.00% in the ITT population (95%CI: 86.29%-99.51%) and 97.96% in the PP population (95%CI: 89.15%-99.95%). CONCLUSION: The new test meal based (13)C-UBT is highly accurate in patients on PPIs and can be used in those unable to stop their PPI treatment.