Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects

DiaSorin

Status: Completed

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

Treatments: Other: Post-Therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT03060733

POST-TREAT Z001

Details and patient eligibility

About

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.

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: 13 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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