Weight Loss Clinical Trial
Official title:
Helicobacter Pylori Sample Collection Protocol PRE-THERAPY
Verified date | February 2019 |
Source | DiaSorin Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 277 |
Est. completion date | May 3, 2018 |
Est. primary completion date | May 3, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | One (1) Location in Bologna, Italy | Bologna | |
United States | One (1) Location in North Carolina | Asheville | North Carolina |
United States | One (1) Location in Virginia | Chesapeake | Virginia |
United States | One (1) Location in Great Neck, New York | Great Neck | New York |
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 Ohio | Mentor | Ohio |
United States | 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 | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
DiaSorin Inc. | ICON Clinical Research |
United States, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Helicobacter pylori Stool Collection | In vitro diagnostic (IVD) device performance | Through Study Completion, an average of 1 year |
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