Clinical Application o 13C Urea Breath Test Diagnosis of Helicobacter pylori Infection and Confirmation of Eradication Following Therapy

Abstract

The present study was aimed at introducing the 13C Urea breath Test (UBT) in clinical settings for initial diagnosis as well as for conformation of eradication of Helicobacter pylori following appropriate therapy, determining the sensitivity, specificity and cost effectiveness of UBT as compared to other conventional tests. During the present period Helicobacter pylori status of 209 patients was checked by 13C urea breath test [ 137 initial diagnosis (ID) 72 follow up (FU) patients]. Besides 13C-UBT, culture, histology and quick urease o biopsy specimens, obtained during upper gastrointestinal endoscopy was also performed for 122 patients. Of 122 patients 10 subjects underwent two or more follow-ups making a total of 13 data sets. The patient found positive at initial diagnosis, were treated with different antibiotic regimens. The patients after four weeks of completion of treatment were subjected to repeated 13CUBT for confirmation of eradication of H. pylori. In follow up UBT, 27 became negative after treatment, whereas 7 were lost to follow-up. Patients testing positive at follow-up UBT underwent further treatment and were followed up further. Twenty-eight patients were still being followed, though data cannot be included in the final report. Several treatment regimens were used for eradication of Helicobacter pylori infection. The data when compiled show that none had an eradication rate of more than 50% when follow-up assessments were made. In most instances several eradication regimens were used before the patient became negative for H. pylori. At the time of initial diagnosis, the patients were assessed simultaneously with 13C UBT along with culture, Clo and histopathology. The study shows that out of 137 ID done 80 were positive by 13C-UBT, 72 by HP, 48 by culture and 69 by Clo. Comparing the diagnostic techniques, it was found 13C-UBT was most sensitive followed by histopathology, quick urease and culture in decreasing order. The final report data confirms the finding of partial data submitted during first report. The comparison and cost effectiveness of all diagnostic tests was also made. The cost of individual tests requiring biopsy specimen will amount to cost of endoscopy and the cost of laboratory analysis. This will amount to cost of 2250 Rs/ test (endoscopy 2000+250-350 for culture- histopathology) The cost of each test will therefore be more than the cost of Urea breath test alone (around 1000Rs). The 13CUBT has the advantage of being a field test and can be performed anywhere and samples analyzed at central analytical facility. 13CUBT is the only non-invasive test that detects the presence of infecting organism in vivo. Incidence of Helicobacter pylori in gastroduodenal disease was also studied. The data collected suggest that Helicobacter pylori is associated with gastric, duodenal ulcers as well as gastritis and duodenitis. It can be concluded from the study results so far that 13C Urea breath test is very sensitive and useful, especially for confirmation of eradication following therapy. The test is now ready to use by interested clinicians and researchers in the country.