Specimen Collection Study for H. Pylori Testing

This is a prospective study designed to acquire and bank human specimens from subjects who are scheduled for routine upper endoscopy for symptoms such as dyspepsia. This study will be conducted at a minimum of 2 sites in the United States. Investigator sites will enroll prospective subjects who meet the inclusion / exclusion criteria. A case report form (CRF) provided by the sponsor will be used to capture basic demographic information (DOB, age, gender, race/ethnicity), medication history, and related clinical information. The CRFs will also record the results of the following tests performed with the gastric biopsy tissue specimens: histology and rapid urease test (RUT).

Inclusion criteria

• Aged 21 and to 75 years.
• Able to read, speak, and understand English or have access to a translator in subject's native language.
• Patients without prior H. pylori eradication treatment.
• Currently not on proton pump inhibitors, antibiotics or bismuth

• Discontinuation at least 2 weeks prior to endoscopy and specimen collection.
• Present with signs and symptoms of dyspepsia [e.g. upper abdominal discomfort or pain]
• Undergo gastric biopsies as part of routine care
• Physician able to provide histology and rapid urease result on biopsy specimens.

Exclusion criteria

• Aged less than 21 years old or older than 75 years
• Unable to provide consent.
• Patients with a history of prior H. pylori eradication therapy.
• Currently on proton pump inhibitors, antibiotics or bismuth and cannot or will not discontinue
• Previous upper gastrointestinal surgery, such as bariatric surgery, Nissen fundoplication, or Roux-en-Y.
• Any unstable or poorly-controlled medical or psychiatric condition.