Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT03060733
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT03060733
Study Brief:
Protocol Section:
NCT03060733