Helicobacter Pylori Sample Collection Protocol POST-THERAPY

DiaSorin Inc.5 sites in 2 countries13 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: 13
Locations: 5
Primary Endpoint: Helicobacter pylori Stool Collection
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

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 14, 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

DiaSorin Inc.

Responsible Party

Sponsor

Eligibility Criteria

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