Objective: Optimal [13C]-urea breath test (UBT) conditions for diagnosis of Helicobacter pylori infection are still being fine-tuned. In the present study we investigated the impact of delaying gastric emptying by different meal substrates or L-DOPA, a drug known to induce gastric stasis, on the performance of the [13C]-UBT.
Methods: A total of 115 patients participated in the study. On two consecutive days, participants ingested [13C]-urea (100 mg) 10 min after either 270 ml of a mixed formula meal (1 Kcal/ml) or an equivalent amount of tap water. In 11 participants two additional tests were performed with or without oral 500 mg L-DOPA given 30 min before [13C]-urea load. The 13C/12C ratio in a basal breath sample was compared with ratios in samples collected 30 and 60 min after [13C]-urea. Histological assessment of H. pylori presence in antral biopsy served as reference standard.
Results: Formula UBT showed excellent specificity (100% at 30 and 60 min) and good sensitivity (97% at both time intervals), whereas water UBT had the same specificity but slightly lower sensitivity (94% at 30 min and 73% at 60 min). In formula UBT, 13C/12C ratios were higher at 60 min than at 30 min (21.7+/-2 vs 17.7+/-1.8 per thousand respectively, p < 0.01, whereas in water UBT 13C/12C ratios were higher at 30 min than at 60 min (13.9+/-1.5 vs 8.4+/-0.09 per thousand respectively, p < 0.01). Pretreatment with L-DOPA did not modify either the sensitivity or the specificity of the UBT.
Conclusions: The performance of the [13C]-urea with a formula meal may not be improved by pharmacologically delaying gastric emptying. A short, water-based test may be a sensible approach to worldwide standardization of the [13C]-UBT for H. pylori infection.