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

Abstract

Aim: To determine the sensitivity and specificity of the ¹³C-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 ¹³C-UBT with the new test meal was performed the next morning.

Results: The sensitivity of the ¹³C-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 ¹³C-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 ¹³C-UBT is highly accurate in patients on PPIs and can be used in those unable to stop their PPI treatment.

Keywords: Helicobacter pylori; New test meal; Prospective randomized clinical trial; Proton pump inhibitors; Urea breath test.

Figure 1

Flow diagram. The patient population and results of Helicobacter pylori diagnosis (based on study criteria and UBT with standard test meal and new test meal after 29 d of PPI treatment). UBT: Urea breath test; ITT: Intention-to-treat; PPI: Proton pump inhibitors; Hp: Helicobacter pylori.

Figure 2

Empirical receiver operating characteristic curve by using cut-off values of 2.0‰, 2.5‰ and 3.0‰ (Per-protocol population, n = 102).