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 pre-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
OTHERNewly Diagnosed
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 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
Exclusion criteria
* Any subject that does not meet the inclusion criteria * 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
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