Evaluation the effects of a homemade ~(13)C-labelled urea capsules in detecting Helicobacter pylori infection

Objective To evaluate the sensitivity, specificity and safety of a homemade13C-labelled urea capsules in detecting Helicobacter pylori infection. MethodsThe study is a randomized, open, parallel-controlled, multicentre clinical trial carriedout in 6 medical units of Beijing and Shanghai. Helicobacter pylori infection wasproven by rapid urease test and Warthin-starry staining. Patients were randomlydivided into trial group taking 75mg homemade 13C-UBT kit or control group taking75mg commercial available 13C-UBT kit. Blood routine test, liver and renal functionwere examined before and 1 week after the UBT test. Results Total 139 subjects wereenrolled into the study, 69 in trial group and 70 in control group. There were nosignificant differences in age and sex between the two groups. There were nosignificant difference in the sensitivity, specificity and precision in detectingHelicobacter pylori infections between the two groups, which were 100%, 88.2% and94.2% in trial group and 97.1%, 94.3% and 95.7% in control group. Decreased WBCin 1 patient and increased ALT level in 2 patients of trial group were mild, no otheradverse effects were found. Conclusion The homemade 13C-UBT kit was aseffective and safe as the import kit, also to be a simple, non-invasive and reliable testfor the diagnosis of Helicobacter pylori infection.