Abdominal Pain, Bloating, Gastric Ulcer, Helicobacter Pylori Infection, Loss of Appetite, Nausea, Stomach Ulcer, Weight Loss
Conditions
Brief summary
The primary objective is to obtain stool samples from post-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.
Detailed description
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.
Interventions
OTHERPost-Therapy
Gastric biopsy tested by composite reference method (CRM) (histology, urease, culture) and stool sample
Sponsors
ICON Clinical Research
DiaSorin Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter pylori Stool Collection | Through Study Completion, an average of 1 year | In vitro diagnostic (IVD) device performance |
Countries
Italy, United States
Outcome results
None listed