Helicobacter Pylori Sample Collection Protocol Pre Therapy Subjects

DiaSorin

Status: Completed

Conditions: Weight Loss; Loss of Appetite; Nausea; Bloating; Helicobacter Pylori Infection; Gastric Ulcer; Stomach Ulcer; Abdominal Pain

Treatments: Other: Newly Diagnosed

Study type: Observational

Funder types: Industry

Identifiers

NCT03060746

PRE-TREAT A001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 277 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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