Helicobacter Pylori Sample Collection Protocol Pre Therapy Subjects
NCT ID: NCT03060746
Last Updated: 2021-12-30
Study Results
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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COMPLETED
277 participants
OBSERVATIONAL
2017-02-14
2018-05-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Newly Diagnosed
Gastric biopsy tested by composite reference method (CRM) (histology, urease, culture) and stool sample
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
22 Years
ALL
No
Sponsors
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ICON Clinical Research
INDUSTRY
DiaSorin Inc.
INDUSTRY
Responsible Party
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Locations
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One (1) Location in Arizonia
Mesa, Arizona, United States
One (1) Location in Mission Hills, California
Mission Hills, California, United States
One (1) Location in Oxnard, California
Oxnard, California, United States
One (1) Location in Florida
Palm Harbor, Florida, United States
One (1) Location in Missouri
St Louis, Missouri, United States
One (1) Location in Great Neck, New York
Great Neck, New York, United States
One (1) Location in North Carolina
Asheville, North Carolina, United States
One (1) Location in Ohio
Mentor, Ohio, United States
One (1) Location in Greenville, South Carolina
Greenville, South Carolina, United States
One (1) Location in Houston, Texas
Houston, Texas, United States
One (1) Location in Virginia
Chesapeake, Virginia, United States
One (1) Location in Bologna, Italy
Bologna, , Italy
Countries
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Other Identifiers
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PRE-TREAT A001
Identifier Type: -
Identifier Source: org_study_id