Clinical study on the efficacy of H. pylori molecular diagnostic kit. Testing with stool and gastric wash waste.
- Conditions
- Helicobacter pylori infection
- Registration Number
- JPRN-UMIN000045892
- Lead Sponsor
- MIZUHO MEDY Co., Ltd.
- Brief Summary
For H. pylori molecular diagnostic kit using gastric wash waste, concordance ratio compared with H. pylori conventional diagnostic method were 93.6% for urea breath test, 93.2% for stool antigen test and 97.9% for culture. And concordance rate with clarithromycin antibiotic susceptibility test was 97.0%. For H. pylori molecular diagnostic kit using stool, sensitivity compared with stool antigen test was 84.2%. And concordance rate with clarithromycin antibiotic susceptibility test was 100%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 143
Not provided
Patients who meet any of the following conditions (1) Patients who did not obtain sufficient samples for the study (2) Patients who have already received H. pylori eradication treatment (3) Patients with serious disabilities (4) Pregnant or potentially pregnant patients (5) Other patients who the attending physician has determined to be unable to participate in the study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method For H. pylori molecular diagnostic kit using gastric wash waste, evaluation of the correlation with H. pylori conventional diagnostic method (urea breath test, stool antigen test, culture) and evaluation of the concordance with clarithromycin antibiotic susceptibility test. For H. pylori molecular diagnostic kit using stool, evaluation of the sensitivity compared with stool antigen test, and evaluation of the concordance with clarithromycin antibiotic susceptibility test.
- Secondary Outcome Measures
Name Time Method