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Background: Helicobacter pylori is a highly prevalent microorganism and risk factor for gastric cancer. In this study, we evaluated the serum levels of PIVKA-II in patients with and without H. pylori. Methods: This study was performed on 90 patients (45 with H. pylori infection and 45 in the control group). After recording demographic information, serum levels of PIVKA-II were measured by the ELISA method. Results: We found no significant difference in PIVKA-II levels between all patients with and without H. pylori infection (P=0.08), but among individuals below 40, H. pylori infection was associated with significantly lower serum PIVKA levels in patients vs. controls (P=0.026). Among men, H. pylori infection was associated with a significantly lower serum PIVKA level than controls (P=0.038). Among all H. pylori-infected patients, females had higher PIVKA levels than males (P=0.037). Conclusion: Our results indicate that (i) serum PIVKA-II levels are lower in H. pylori-infected individuals under 40 and men than in non-infected controls, and ii) among all H. pylori-infected patients, serum PIVKA-II levels are lower in men than women and in those under 40 years of age compared to those 40 or above. [ABSTRACT FROM AUTHOR]