Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-14

Study Completion Date

2018-05-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Post-Therapy

Gastric biopsy tested by composite reference method (CRM) (histology, urease, culture) and stool sample

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No