Helicobacter Pylori Sample Collection Protocol PRE-THERAPY

DiaSorin Inc.12 sites in 2 countries277 target enrollmentFebruary 14, 2017

ConditionsHelicobacter Pylori Infection Gastric Ulcer Nausea Abdominal Pain Weight Loss Stomach Ulcer Loss of Appetite Bloating

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Helicobacter Pylori Infection
Sponsor: DiaSorin Inc.
Enrollment: 277
Locations: 12
Primary Endpoint: Helicobacter pylori Stool Collection
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 14, 2017

End Date

May 3, 2018

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

DiaSorin Inc.

Responsible Party

Sponsor

Eligibility Criteria

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