Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
DiaSorin Inc.
With
ICON Clinical Research
Stools will be collected and tested, at a later date, in a clinical performance study with an investigational H. pylori antigen assay. This study will be coordinated by the Sponsor.
Age
22–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult ≥ 22 years, either gender
Subject is symptomatic showing signs and symptoms of gastritis
Subject is not under evaluation for post-therapy follow up diagnosis
Subject is already undergoing upper EGD and obtaining a gastric biopsy as part of routine care for H. pylori diagnosing
Biopsy is obtained from antrum and/or corpus and is tested by CRM
At least two of the three CRM tests are performed
Subject whose EGD with biopsy procedure occurred ≤ 7 days prior to stool collection
Willing and able to sign the IRB approved Informed Consent form for this project, or able to provide Informed Consent in accordance with 21 CFR 50 Subpart B
Subject with current severe H. pylori infection
Subject ingested compounds that may interfere with detection of H. pylori e.g. 4 weeks for all antibiotics, 2 weeks for Bismuth preparations or proton pump inhibitors prior to EGD/collection
Subject recently tested, less than 3 months and knowledge of H. pylori absence
Subject tested, less than one year and knowledge of H. pylori presence but NOT undergone prescribed treatment
Pregnant or lactating
Inability or unwilling to perform required study procedures
Subject is unable or unwilling to provide informed consent
