Helicobacter pylori determination: Evaluation of Existing non-invasive methods and Linkage to Innovation” - The HELI-study
Recruiting
- Conditions
- Helicobacter pylori, feces sample, urea breath testHelicobacter pylori, fecestest, ademtest
- Registration Number
- NL-OMON25263
- Lead Sponsor
- Erasmus Medical Center Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 184
Inclusion Criteria
aged 18 years or older
- referred for urea breath test
Exclusion Criteria
- Use of antibiotics/bismuth in the past 4 weeks
- Use of PPI in the past 2 weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the accuracy of H. pylori determination in FIT with golden standard UBT by assessing: Positivity Rate (PR), Positive Predictive Value (PPV), Negative Predictive Value (NPV), sensitivity and specificity
- Secondary Outcome Measures
Name Time Method 1. To compare the accuracy of H. pylori determination in FIT with SAT and serology by assessing PPV/NPV, sensitivity/specificity<br><br /><br /><br>2. To compare the accuracy of SAT and serology with UBT by assessing PPV/NPV, sensitivity/specificity <br>