Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects
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Ages Eligible for Study:
22 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects are evaluated for H. pylori infectious status prior to eligibility. Evaluation includes use of a diagnostic H. pylori test, such as, an FDA cleared UBT or an FDA cleared Fecal Stool Antigen. Infectious status must be determined positive for H. pylori for subject eligibility.
Eligible subjects are undergoing EGD with biopsy for H. pylori infectious status after completion of therapy
Adult ≥ 22 years, either gender
Subject previously diagnosed with H. pylori infection
Subject received and completed FDA approved treatment option
Minimum of 4 weeks to one year has lapsed after completion of FDA approved treatment option
Subject with a post therapy positive result from a FDA cleared UBT or FDA cleared Fecal Antigen Test
Subject will undergo EGD and gastric biopsy as part of routine care to measure H. pylori post-therapy response
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 occurred ≤ 7 days prior to stool collection
Willing and able to sign the IRB approved Informed Consent form for this study project
Subject with current severe H. pylori infection
Subject ingested compounds that may interfere with detecting of H. pylori, e.g. 4 weeks for antibiotics and 2 weeks for Bismuth preparations or proton pump inhibitors prior to collection
Pregnant or lactating
Inability or unwilling to perform required study procedures
Subject is unable or unwilling to provide informed consent