Background: Eradication of Helicobacter pylori is not routinely recommended for the symptomatic relief and the prevention of gastric cancer in patients with functional dyspepsia. The present study investigated a useful indicator of H. pylori eradication in such patients by determining the optimal cutoff value of a C-13-urea breath test (UBT). Methods: One hundred dyspeptic patients participated in the study. Dyspepsia was scored, and a C-13-UBT administered. A level of delta C-13-UBT of >4parts per thousand was diagnosed as H. pylori-positive. After the stomach was endoscopically sprayed with phenol red, biopsy specimens were taken from the antrum, body and cardia of the stomach for the assessment of H. pylori density, and activity (neutrophil infiltration) and degree (lymphocyte infiltration) of gastritis. Results: Correlation between delta C-13-UBT and dyspepsia score was not found. Delta C-13-UBT significantly correlated with H. pylori density score in the total stomach (r=0.53, P<0.0001), neutrophil (r=0.34, P=0.0005) and lymphocyte score (r=0.69, P<0.0001). Twenty-six of the 100 subjects had a neutrophil score of greater than or equal to4, lymphocyte score of greater than or equal to4, and H. pylori score of greater than or equal to4. Their 95% confidence interval of mean was 58.2parts per thousand, which reflects moderate to marked acute and chronic gastritis, and dense H. pylori colonization. Conclusion: The C-13-UBT is a reliable semiquantitative test to assess H. pylori density and the activity and degree of gastritis. It is proposed that H. pylori eradication therapy might be beneficial for patients with functional dyspepsia with a delta C-13-UBT of >58.2parts per thousand. (C) 2003 Blackwell Publishing Asia Pty Ltd.